דרושים Associate Pricing & Quoting ב-West Pharma ב-ארהב

• Provide strategic leadership and oversight to ensure regulatory compliance across the product lifecycle.
• Manage highly complex regulatory projects, including drug-device combination products.
• Drive pre-market and post-market regulatory initiatives for successful product commercialization and compliance.
• Collaborate with internal teams such as Research and Development, Clinical, QA, Operations, Commercial, Legal, and Finance to execute key projects.
• Manage and support regulatory personnel in accordance with West and government requirements.
• Assist with US, EU, and ROW clinical programs and regulatory approvals.
• Enhance cross-functional effectiveness and drive continuous improvement in regulatory and quality operations.
• Maintain an up-to-date understanding of health authority guidelines and regulations to shape future regulatory strategies.

• Bachelor's Degree In science, math, engineering, or related discipline required
• Master's Degree In science, math, engineering, or related discipline preferred
• PhD In science, math, engineering, or related discipline preferred

• Bachelor’s Degree with 10+ years; Master’s Degree/PhD 5-8 years regulatory/pharmaceutical experience required
• Experience directly interacting and presenting to project teams, customers, industry groups required

• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Excellent interpersonal, communication and listening skills.
• Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• 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
• Able to comply with the company’s safety and quality policies at all times

• 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
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 related activities
• 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 follow directions, 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

This Full-time onsite role will be supervising, coordinating and administering the site Quality Control systems compliance: Document Control, Nonconformance/ Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPA’s. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.

• Qualify inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations, escalations, how to perform containment/bracketing, and initial event triage activities.
• Ensure deviation/ nonconformance reports and OOS’s are completed properly, including root cause investigation (if required), effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies, Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/ recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities, equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSA’s for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

• Highschool Diploma required.
• Bachelor's degree in Quality, Engineering, Science or equivalent experience preferred.

• Minimum of 3 years of related experience analyzing information, documentation skills, promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s)

• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts, practices, AQL sampling plans for attribute and dimensional inspection. Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with GMP/GDP Regulations
• 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 make independent quality decisions under pressure, if necessary
• 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

• Manufacturing environment requires strict adherence to standards. Working environment is a manufacturing facility and must be able to tolerate fumes and particulate generated from the processes.
• 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 have competing resources, while maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities 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.

• 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
• 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
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual

1st Shift Position, with occasional adjustments to accomodate 2nd/3rd shift interactions

Conducting Investigations:

• Investigate a wide range of issues, including harassment, discrimination, retaliation, ethics violations, and policy breaches.
• Gather evidence by interviewing complainants, witnesses, and others involved.
• Review relevant documents and policies to establish facts and determine outcomes.

Reporting and Analysis:

• Prepare comprehensive, factual, and well-documented investigation reports with findings and recommendations for action.
• Maintain accurate and confidential records of all investigative activities and case tracking.
• Analyze case data to identify trends, inform policy updates, and develop proactive strategies.

Auditing and Compliance:

• Conducts audits on site compliance to HR Policy as well as Employee Culture.
• Conduct regular audits of employee relations cases and documentation to ensure adherence to established procedures and legal requirements.
• Stay up-to-date on federal, state, and local employment laws and best practices.

Consultation and Guidance:

• Provide expert advice and consultation to HR, managers, and leaders on employee relations matters and appropriate disciplinary actions.
• Partner with Legal and Compliance departments to ensure consistent and appropriate handling of cases.

Process Improvement:

• Proactively identify opportunities to improve Employee Relations processes, policies, and tools.
• Develop and facilitate training for employees and managers on employee relations topics and conflict resolution.

Bachelor's degree in Human Resources or a related field and/ or five years of directly related experience, or equivalent experience.

• Minimum of 5 years of relevant experience Human Resources.

• Exceptional strategic thinking, problem-solving, and organizational skills.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate with senior leadership and legal counsel.

• Responsible for the development and execution of sterilization strategies to ensure medical devices meet functionality and design standards.
• Perform risk assessments and validation studies to ensure the effectiveness and safety of sterilization methods and protocols.
• Develop, maintain, and update sterilization processes in compliance with industry standards and regulatory requirements.
• Work with R&D, Quality Engineering, and other departments to ensure product integrity during product introductions, sustaining changes, and transfers.
• Offer technical support and insight regarding sterilization processes and regulations to internal and external stakeholders.
• Analyze and monitor data to identify trends, driving improvements in sterilization processes.
• Identify, investigate, and resolve issues related to sterilization equipment and processes efficiently.
• Participate in audits to ensure compliance with regulatory standards, providing recommendations for continuous improvement.
• Train and mentor R&D teams on sterilization processes, procedures, and regulatory requirements.
• Oversee the commissioning, maintenance, and validation of sterilization equipment to meet operational and energy efficiency standards.
• Identify and drive process improvements initiatives and cost-saving opportunities related to sterilization systems.
• Manage regulatory filings and respond to inquiries from regulatory bodies concerning sterilization processes.
• Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
• Adhere to West compliance and safety policies and procedures at all times.
  

• Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
• Masters Degree in related field preferred

• 5+ years of experience in development of sterilization, medical devices, or pharmaceuticals.
• Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required.
• Experience leading sterilization development workstreams from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Must have effective problem-solving abilities.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Able to comply with the company’s safety policy at all times.

In this role, you will be the primary point of contact for all KRONOS-related inquiries. You will be responsible for providing comprehensive support and assistance across various administrative tasks to ensure accuracy, compliance, and efficiency. The role involves closely collaborating with HR managers, supervisors, and the payroll department to maintain precise and timely payroll processing. Additionally, you will participate actively in audits and system upgrades to enhance the overall effectiveness of the operations.

• Assist and support Kronos time and attendance system for sites.
• Help remediate issues related to time and attendance, including identification and correction of inaccurate records.
• Help troubleshoot Kronos issues with HR managers and supervisors.
• Interface with Exton Payroll Department.
• On a biweekly basis, assist in finalizing the Kronos data in preparation for payroll processing.
• Interface with contingency employee agencies for time-related support.
• Participate in audits to ensure legal and policy compliance.
• Provide Kronos training to managers and employees.
• Participate in testing of system upgrades and new software
• Assist in preparation of vacation payout calculations for terminated hourly employees
• Complete all Verification of Employment inquiries.
• Assist in review of data entry of hourly and agency employees in HR system.
• Serve as temporary backup other Kronos administrators.
• Assist in creating and maintaining Job Aides..
• Comply with government regulations and company policy
• Other duties as assigned

• High School or equivalent experience is required.
• 0 to 3 years of either HRIS or payroll system experience.

• Excellent communication and interpersonal skills
• Strong organizational and time management skills
• Detail Oriented
• Proficient in Excel
• 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

In this role, you will provide quality operations support through internal customer engagement. Lead and support continuous improvement for product and processes. Support plant functional areas such as engineering, operations, and maintenance by conducting data and document review/approval as it pertains to investigations and change management.

• Review Issue Bracketing based on issue documentation, process knowledge, and available control strategies, revising the bracket as necessary.
• Identify acceptable remediation activities for issues based on the issue documentation, investigations, and process capabilities.
• Perform Risk Assessment to support remediation justification.
• Use Trending, RCA, and Change Management tools to drive issue reduction activities.
• Use all necessary quality systems in compliance with system and procedural requirements.
• Interact with internal and external clients as needed.
• Meet individual and departmental goals as required.
• Understand and apply applicable FDA and ISO regulations/standards to the plant quality system.
• Other duties as assigned.

• Ability to honestly include two of the following statements in a self-assessment:
  • I have a demonstrated and reliable sense of the best of many options in the face of both limited or excessive information about the problem, the potential solutions, or both.
  • I am energized by garnering support for change through organizing, engaging, and inspiring those that will be responsible for implementing and maintaining the change.
  • I enjoy personally identifying and completing the fine details necessary to complete tasks or close out a project.
• Learn, understand and utilize complex sequences.
• Capability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Knowledge of West's fabrication and finishing processes.
• Strong verbal and written communication skills and attention to detail required.
• Prior use of LEAN or 6-Sigma tools to achieve a set target.
• Experience with the use of SAP, MasterControl, and Excel's "Named Tables", or Minitab.
• Experience with UX design theory or HCD practices.

• GED or HS diploma, Bachelor’s degree preferred
• 3+ years of experience in a cGMP environment

• Able to maintain confidentiality appropriately for role.
• Read and interpret data, information and documents to make independent and sound judgments.
• Learn and apply new information or new skills.