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דרושים Sr Quality Manager ב-West Pharma ב-United States, Williamsport

מצאו את ההתאמה המושלמת עבורכם עם אקספוינט! חפשו הזדמנויות עבודה בתור Sr Quality Manager ב-United States, Williamsport והצטרפו לרשת החברות המובילות בתעשיית ההייטק, כמו West Pharma. הירשמו עכשיו ומצאו את עבודת החלומות שלך עם אקספוינט!
חברה (1)
אופי המשרה
קטגוריות תפקיד
שם תפקיד (1)
United States
אזור
Williamsport
נמצאו 11 משרות
Today
WP

West Pharma Senior Quality Manager United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development. As a member of the Site Leadership Team,...
תיאור:
Job Summary

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

Essential Duties and Responsibilities
  • Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
  • As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
  • The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
  • Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
  • Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
  • Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
  • Perform the necessary functions in support of the Williamsport Quality System
    • Designated ISO 13485 Management Representative
    • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
  • In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
  • Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
  • QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
  • Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
  • Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
  • Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
  • Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
  • Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
  • Responsible and accountable for quality departmental budget
  • Other duties as assigned
Education
  • Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
  • Master’s degree preferred
Work Experience
  • 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
  • 8+ Years of supervisory experience required.
  • 5+ Years of experience working with injection molding processes preferred.
  • 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.
Preferred Knowledge, Skills and Abilities
  • Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
  • Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
  • Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
  • Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
  • Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
  • Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Project Management experience preferred
Additional Requirements
  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
  • Excellent written and oral communication skills
  • Medical component and device manufacturing require strict adherence to standards.
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
  • Read and interpret data, information, and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Demonstrates enthusiasm, takes accountability, and drives for results.
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
  • Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
  • Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
  • Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
  • Able to lead and manage the performance of a multi-functional team.
  • Able to organize and prioritise tasks, must be detail orientated and self-motivated.
  • Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to always comply with the company’s safety and quality policy
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Show more
Yesterday
WP

West Pharma Manager Sourcing United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development. As a member of the Site Leadership Team,...
תיאור:
Job Summary

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

Essential Duties and Responsibilities
  • Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
  • As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
  • The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
  • Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
  • Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
  • Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
  • Perform the necessary functions in support of the Williamsport Quality System
    • Designated ISO 13485 Management Representative
    • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
  • In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
  • Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
  • QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
  • Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
  • Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
  • Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
  • Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
  • Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
  • Responsible and accountable for quality departmental budget
  • Other duties as assigned
Education
  • Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
  • Master’s degree preferred
Work Experience
  • 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
  • 8+ Years of supervisory experience required.
  • 5+ Years of experience working with injection molding processes preferred.
  • 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.
Preferred Knowledge, Skills and Abilities
  • Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
  • Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
  • Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
  • Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
  • Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
  • Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Project Management experience preferred
Additional Requirements
  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
  • Excellent written and oral communication skills
  • Medical component and device manufacturing require strict adherence to standards.
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
  • Read and interpret data, information, and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Demonstrates enthusiasm, takes accountability, and drives for results.
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
  • Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
  • Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
  • Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
  • Able to lead and manage the performance of a multi-functional team.
  • Able to organize and prioritise tasks, must be detail orientated and self-motivated.
  • Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to always comply with the company’s safety and quality policy
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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משרות נוספות שיכולות לעניין אותך

Yesterday
WP

West Pharma Sr Mgr Operational Excellence United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications,...
תיאור:
Job Summary

This role will require you to develop strategic plans for maturing the lean culture and efficiency within the site and West. You’ll provide leadership, influence and team development on lean thinking and lean processes at all levels in the organization. You will distill and work across the site to implement the West Business System. You will govern site lean savings, goals and objectives. You will lead site wide efficiency projects. A strong desire to engage teams across all levels and implement improvements assures that you are a good fit for the role.

Essential Duties and Responsibilities
    • Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
    • Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
    • Working with site teams identify annual site savings, manage the tracking, validation and communication of savings. Ensuring contingency plans are implemented for at risk projects.
    • Working with the Site Leadership and operations teams develop robust Lean Daily Management systems including leader standard work, Tiered meetings, daily Gemba’s
    • Participate in the development and implementation of the West Business System (WBS) on site, working with stakeholders to sustain and improve operational standards on the site.
    • Organize and embed the Operational Excellence systems (Kaizens, 5S events, Gemba’s, Lean programs, GB/BB projects and certifications, LDMS, Maturity model, Etc.)
    • Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
    • Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
    • Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
    • Manage the continuous improvement of the West Kaizen program.
    • Work with all departments to develop and maintain meaningful lean metrics, status update reporting, and documentation of identified and implemented projects.
    • Work with the relevant stakeholders on new business implementation – facilitating value stream mapping, material flow modelling and layout review.
    • Network, assist and support lean efforts and best practices across the organization through participating in events and sharing of documentation and improvements.
    • Continuous updating and development of lean implementation plans and strategic future stream maps.
    • Other duties as assigned
Education
  • Bachelor’s degree in Engineering, Business or Statistics concentration; or recognized equivalent
  • Master’s degree is preferred.
Work Experience
  • 10+ years’ experience in a manufacturing/production environment
  • Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies.
  • Medical Device industry experience preferred.
Preferred Knowledge, Skills and Abilities
    • Must have good interpersonal/leadership/influential skills and be able to interface with all departments and team member levels.
    • Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
    • Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
    • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
    • Work closely with other functions to maximize achievement through a cooperative environment
    • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
    • Able to comply with the company’s safety policy at all times
    • Able to comply with the company’s quality policy at all times.
License and Certifications
  • Manufacturing\Six Sigma Green Belt Certification Upon Hire required and
  • Health Services\CSSBB - Six Sigma Black Belt Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Safely work in construction environments
  • Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
  • Must follow and comply with Plant’s Dress and Hygiene Code (SOI)
Show more

משרות נוספות שיכולות לעניין אותך

21.11.2025
WP

West Pharma Sr Quality Manager United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications,...
תיאור:
Job Summary

This role will require you to develop strategic plans for maturing the lean culture and efficiency within the site and West. You’ll provide leadership, influence and team development on lean thinking and lean processes at all levels in the organization. You will distill and work across the site to implement the West Business System. You will govern site lean savings, goals and objectives. You will lead site wide efficiency projects. A strong desire to engage teams across all levels and implement improvements assures that you are a good fit for the role.

Essential Duties and Responsibilities
    • Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
    • Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
    • Working with site teams identify annual site savings, manage the tracking, validation and communication of savings. Ensuring contingency plans are implemented for at risk projects.
    • Working with the Site Leadership and operations teams develop robust Lean Daily Management systems including leader standard work, Tiered meetings, daily Gemba’s
    • Participate in the development and implementation of the West Business System (WBS) on site, working with stakeholders to sustain and improve operational standards on the site.
    • Organize and embed the Operational Excellence systems (Kaizens, 5S events, Gemba’s, Lean programs, GB/BB projects and certifications, LDMS, Maturity model, Etc.)
    • Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
    • Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
    • Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
    • Manage the continuous improvement of the West Kaizen program.
    • Work with all departments to develop and maintain meaningful lean metrics, status update reporting, and documentation of identified and implemented projects.
    • Work with the relevant stakeholders on new business implementation – facilitating value stream mapping, material flow modelling and layout review.
    • Network, assist and support lean efforts and best practices across the organization through participating in events and sharing of documentation and improvements.
    • Continuous updating and development of lean implementation plans and strategic future stream maps.
    • Other duties as assigned
Education
  • Bachelor’s degree in Engineering, Business or Statistics concentration; or recognized equivalent
  • Master’s degree is preferred.
Work Experience
  • 10+ years’ experience in a manufacturing/production environment
  • Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies.
  • Medical Device industry experience preferred.
Preferred Knowledge, Skills and Abilities
    • Must have good interpersonal/leadership/influential skills and be able to interface with all departments and team member levels.
    • Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
    • Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
    • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
    • Work closely with other functions to maximize achievement through a cooperative environment
    • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
    • Able to comply with the company’s safety policy at all times
    • Able to comply with the company’s quality policy at all times.
License and Certifications
  • Manufacturing\Six Sigma Green Belt Certification Upon Hire required and
  • Health Services\CSSBB - Six Sigma Black Belt Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Safely work in construction environments
  • Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
  • Must follow and comply with Plant’s Dress and Hygiene Code (SOI)
Show more

משרות נוספות שיכולות לעניין אותך

24.08.2025
WP

West Pharma Quality Assurance Technician United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Review and approval of metrology reports, where appropriate, for batch release and validation purposes. New product validation, analysis and reporting. Quality support to Engineering and Production Departments. Establish and maintain...
תיאור:

Training for this position will be Monday - Friday Day shift. In Fourth Quarter of 2025, or First Quarter 2026 this position will change to a 2-2-3-2 12 hour night shift schedule.

Schedule-12 hour night shift 5:45p-6am

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

Essential Duties and Responsibilities
  • Review and approval of metrology reports, where appropriate, for batch release and validation purposes
  • New product validation, analysis and reporting.
  • Quality support to Engineering and Production Departments.
  • Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
  • Liaise with customers and suppliers on new and existing projects.
  • Receiving and inspection of incoming goods and materials.
  • Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
  • Maintain good communications both internally and externally.
  • Ensures that all metrology equipment is correctly calibrated.
  • Assists shift personnel with quality issues and/or measurement techniques.
  • Assists in problem resolution with customers.
  • Perform periodic audits as requested and completes necessary documentation.
  • Archives quality records, samples and log procedures.
  • Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
  • Batch paperwork review and final decision to release product for shipment.
Additional Responsibilities
  • Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintain a clean, orderly, and safe workstation and environment at all times.
  • Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
  • Exhibit regular, reliable, and punctual attendance.
  • Perform other duties as assigned based on business needs.
  • Keep current with new GMP compliance guidance and internal QA procedures
  • Support new GMP compliance guidance and Data Integrity initiatives
Education
  • High School Diploma or GED Required.
  • Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment
Work Experience
  • 3 years of job-related experience; in QA/QC and the use of measuring equipment.
Preferred Knowledge, Skills and Abilities
  • Able to be aware of all relevant standard operating procedures as per Company policy
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
  • Willingness to learn new and review new analytical techniques
  • Meet individual and departmental goals as required
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Ability to learn, understand, and remember normal tasks.
  • Ability to hear, speak, and understand conversation in English in a normal tone of voice.
  • Must maintain the ability to work well with others in a variety of situations.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Read and interpret data, information and documents
  • Work under deadlines with constant interruptions
Show more

משרות נוספות שיכולות לעניין אותך

24.08.2025
WP

West Pharma Value Stream Manager United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Champion a culture of health and safety in accordance with the highest standards of regulatory compliance. End to end ownership for the full business value stream. Build and maintain an...
תיאור:
Essential Duties and Responsibilities
  • Champion a culture of health and safety in accordance with the highest standards of regulatory compliance.
  • End to end ownership for the full business value stream.
  • Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
  • Support the Customer Account Manager in developing and executing a compelling strategic sales / business plan for the continued growth of the Value Stream
  • Commercial leadership and management of Value Stream customers, including full operational P&L responsibility.
  • Lead and drive the highest standards in Operational performance, 6S, people development to build on the culture of continuous improvement and growth, to deliver tangibly high quality performance outcomes
  • Drive excellent cross functional relationships both within the Value Stream and companywide.
  • Demonstrate excellent leadership visibility to drive engagement levels across the organisation.
  • Development of the team to support Value Stream and performance and growth, including the recruitment, identification, development and retention of talent in the Value Stream.
  • Strong coaching / development of team using development and retention plans as appropriate.
  • Other duties assigned.
Education
  • Education: Bachelor's in a technical discipline to include: Business, Operations or Engineering.
Work Experience
  • Experience: 8-10 years of experience in leading and managing a diverse team in a fast paced and highly regulated environment.
  • 3+ years’ experience of working in medical devices sector or similar is an advantage.
  • Ideally have injection molding and tooling knowledge / expertise.
Preferred Knowledge, Skills and Abilities
  • General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation.
  • Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
  • Experience working with ISO9000, FDA and cGMP required.
  • Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
  • Ability to write routine reports, correspondence and process documents.
  • Ability to speak effectively before groups and employees in the organization.
  • Write monthly progress reports and capital request.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this job description.
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times.
  • Able to comply with the company’s quality policy at all times.
Additional Requirements
  • Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
  • May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
  • The ability to be able to lift and carry various items up to 50lbs.
  • Minimal travel
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משרות נוספות שיכולות לעניין אותך

22.08.2025
WP

West Pharma Quality Assurance Technician United States, Pennsylvania, Williamsport

Limitless High-tech career opportunities - Expoint
Review and approval of metrology reports, where appropriate, for batch release and validation purposes. New product validation, analysis and reporting. Quality support to Engineering and Production Departments. Establish and maintain...
תיאור:

Training for this position will be Monday - Friday Day shift. Fourth Quarter 2025 or First Quarter 2026 this position will change to a 2-2-3-2 12 hour day shift.

Schedule- 12 hour day shift

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

Essential Duties and Responsibilities
  • Review and approval of metrology reports, where appropriate, for batch release and validation purposes
  • New product validation, analysis and reporting.
  • Quality support to Engineering and Production Departments.
  • Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
  • Liaise with customers and suppliers on new and existing projects.
  • Receiving and inspection of incoming goods and materials.
  • Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
  • Maintain good communications both internally and externally.
  • Ensures that all metrology equipment is correctly calibrated.
  • Assists shift personnel with quality issues and/or measurement techniques.
  • Assists in problem resolution with customers.
  • Perform periodic audits as requested and completes necessary documentation.
  • Archives quality records, samples and log procedures.
  • Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
  • Batch paperwork review and final decision to release product for shipment.
Additional Responsibilities
  • Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintain a clean, orderly, and safe workstation and environment at all times.
  • Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
  • Exhibit regular, reliable, and punctual attendance.
  • Perform other duties as assigned based on business needs.
  • Keep current with new GMP compliance guidance and internal QA procedures
  • Support new GMP compliance guidance and Data Integrity initiatives
Education
  • High School Diploma or GED Required
  • Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment
Work Experience
  • 3 years of job-related experience; in QA/QC and the use of measuring equipment.
Preferred Knowledge, Skills and Abilities
  • Able to be aware of all relevant standard operating procedures as per Company policy
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
  • Willingness to learn new and review new analytical techniques
  • Meet individual and departmental goals as required
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Ability to learn, understand, and remember normal tasks.
  • Ability to hear, speak, and understand conversation in English in a normal tone of voice.
  • Must maintain the ability to work well with others in a variety of situations.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Read and interpret data, information and documents
  • Work under deadlines with constant interruptions
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משרות נוספות שיכולות לעניין אותך

Limitless High-tech career opportunities - Expoint
Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development. As a member of the Site Leadership Team,...
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Job Summary

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

Essential Duties and Responsibilities
  • Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
  • As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
  • The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
  • Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
  • Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
  • Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
  • Perform the necessary functions in support of the Williamsport Quality System
    • Designated ISO 13485 Management Representative
    • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
  • In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
  • Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
  • QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
  • Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
  • Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
  • Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
  • Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
  • Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
  • Responsible and accountable for quality departmental budget
  • Other duties as assigned
Education
  • Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
  • Master’s degree preferred
Work Experience
  • 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
  • 8+ Years of supervisory experience required.
  • 5+ Years of experience working with injection molding processes preferred.
  • 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.
Preferred Knowledge, Skills and Abilities
  • Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
  • Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
  • Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
  • Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
  • Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
  • Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Project Management experience preferred
Additional Requirements
  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
  • Excellent written and oral communication skills
  • Medical component and device manufacturing require strict adherence to standards.
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
  • Read and interpret data, information, and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Demonstrates enthusiasm, takes accountability, and drives for results.
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
  • Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
  • Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
  • Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
  • Able to lead and manage the performance of a multi-functional team.
  • Able to organize and prioritise tasks, must be detail orientated and self-motivated.
  • Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to always comply with the company’s safety and quality policy
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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בואו למצוא את עבודת החלומות שלכם בהייטק עם אקספוינט. באמצעות הפלטפורמה שלנו תוכל לחפש בקלות הזדמנויות Sr Quality Manager בחברת West Pharma ב-United States, Williamsport. בין אם אתם מחפשים אתגר חדש ובין אם אתם רוצים לעבוד עם ארגון ספציפי בתפקיד מסוים, Expoint מקלה על מציאת התאמת העבודה המושלמת עבורכם. התחברו לחברות מובילות באזור שלכם עוד היום וקדמו את קריירת ההייטק שלכם! הירשמו היום ועשו את הצעד הבא במסע הקריירה שלכם בעזרת אקספוינט.