דרושים Quality Assurance ב-United States, Pennsylvania, West Whiteland Township

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• 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.

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch. Primary responsibilities center on being able to develop, implement and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities related to the management of CGMP analytical method lifecycle (e.g. management of reference standard, assay control, critical reagents and materials, product specification and sampling plan processes). The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position.

Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing.
Establishing and maintaining strategies for method and/or process implementation, continuous improvement initiatives, and method transfer and validation processes.
Developing strategies and approaches for special studies, as applicable.
Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff. Executional tasks include but are not limited to:
• Supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing. This includes efforts as an individual contributor that may include but are not limited to the review and approval of data in raw and reported forms as well as training staff in compliance or technical principles
• Providing oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities
• Providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports. Executing these tasks as an individual contributor, as applicable
Engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations.

Education
Minimum: BS/MS in relevant discipline
Preferred: PhD in Biochemistry, Analytical Chemistry

Experience
10-15+ years (BS/MS/PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development

Specialized Knowledge:
LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Important notice to Employment Agencies - Please Read Carefully

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• 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
• Observe and interpret situations, analyze and solve problems

The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.

• Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
• Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements.
• Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
• Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
• Identify and implement meaningful metrics and KPI’s to measure and improve WSS laboratory compliance.
• Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
• Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
• Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.

• Bachelor’s Degree and/or Masters in Science Technology or Engineering.
• Master's Degree preferred

• 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
• Expertise of cGMP requirements, ISO standards and FDA regulations

• Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
• Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
• Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
• Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Thorough understanding of validation activities and risk management principles and techniques
• Fluent in English
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• 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.

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with clients.

In this role as a Quality Assurance Specialist at West Analytical Lab Services, you will be instrumental in providing quality support and ensuring the continuity of cGMP compliance, in line with corporate policies and procedures. Your responsibilities will include ensuring the lab's adherence to regulatory, compendial, ISO, and West requirements while reviewing the quality of work completed by lab personnel. You will be tasked with analyzing data, recommending changes, and verifying their effectiveness, alongside reviewing and approving investigations, corrective actions, validation documents, and relevant change control documentation. By leveraging your knowledge and experience, you will drive initiatives to enhance system effectiveness and efficiency, ensure timely completion of assignments, and support the development and review of lab procedures and work instructions. Additionally, you will play a key role in resolving quality issues, maintaining consistent application of quality requirements, and contributing to the technical writing and editing of procedures and documentation.

• Provides QA support to Analytical Lab ensuring compliance to regulatory/compendial, ISO and West requirements.
• Reviews the quality of work completed by the Lab personnel to ensure it meets regulatory/compendial requirements, ISO, West procedures, and customer requirements.
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
• Reviews and approves the investigations, corrective actions, validation documents and reports, and change control documentation related to Exton Lab.
• As appropriate, use knowledge and experience to take initiatives to improve the effectiveness and/or efficiency of systems.
• Ensures that assignments are completed on time, and at the required level, etc.
• Provides support for the development of procedures and work instructions for the lab including technical editing and writing.
• Participates in the review of lab procedures and work instructions.
• Resolves issues within Quality to ensure consistent application of quality requirements.
• Participates in internal quality audits and customer audits.
• Reviews and provides approval of materials from external warehouses.
• Provides client’s supplier qualification questionnaire response.
• Prepares data and information to be discussed during Management Review and ensure that this review is performed per procedure.
• Supports corporate harmonization initiatives as they pertain to the lab management system.
• Works independently with minimal supervision.
• Performs other duties as assigned based on business needs.

• Strong communication and technical writing skills, interpretation of data, and interpersonal skills.
• 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.
• Observe and interpret situations, analyze, and solve problems.

• Education or Equivalent Experience: Bachelor's in scientific discipline preferred. Applicable work background and experience may be considered as a substitute.

• Minimum 3 years of experience in regulated Quality Assurance / Quality Control required
• Minimum 3 years of experience in medical devices or pharmacy industry preferred

• Knowledge of cGMP requirements and ISO standards
• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with managing Document Control activities within a regulated industry
• Familiarity with Master Control, SAP/ERP system and SharePoint
• Excellent written and verbal communication skills
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to be aware of all relevant SOPs per Company policy as they are related to the position covered by this Job Description.
• Must have effective problem solving and interpersonal skills
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers

In this role, you willberesponsible for conducting analytical testing with a focus on performance and functionality testing (force testing) and container closure integrity (CCI) assessments in compliance with Good Manufacturing Practice (GMP) regulations. This role involves method execution, documentation, and collaboration with cross-functional teams to ensure the quality and integrity of pharmaceutical packaging. The ideal candidate will have experience with physical and mechanical testing methodologies, strong analytical skills, and a thorough hands-on understanding of GMP requirements.

• Conduct performance and functionality testing using force-based technique (Instron machine).
• Conduct container closure integrity (CCI) testing using helium leak technique.
• Use instrumentation both qualitatively and quantitatively where appropriate. Independently troubleshoot instrumentation.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Collaborate with cross-functional teams.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigations, OOS, and OOT as required and resolve problems in the lab.
• Apply required cGMP regulations and follow all policies and procedures.
• Apply internal QA procedures.
• Adhere to established laboratory safety procedures.
• Other duties as assigned.

• Bachelor’s degree or equivalent experience in chemistry, engineering or closely related fields.

• Minimum 3 years of professional experience in a GMP lab environment required
• Experience in pharmaceutical or packaging field and implementing laboratory training programs required

• Working knowledge and experience with at least one of the skills below
  • Physical / mechanical testing such as Instron or Zwick
  • Container closure integrity (CCI) via helium leak
• Experience in analytical testing in GMP environment.
• Ability to work independently, with minimal guidance and an attention to detail
• Able to comply with all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to follow directions, prioritize tasks, and work independently.
• Must have excellent interpersonal, written and verbal communication skills.
• Must be proficient in Microsoft Office tools and capable to learn other software programs.
• Able to review regulatory code and learn safety standards.

• Physical:
  • Must be able to stand for long periods of time.
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures).
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents.