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Title:  Senior Specialist, Quality Systems

Requisition ID:  56259
Date:  Sep 22, 2022
Location: 

Exton, Pennsylvania, US

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

 Job Summary:

This role will lead Quality System related activities for raw material evaluation and/or qualification relating to West supplier driven raw material changes and second source initiatives to ensure no impact to the quality of West Products. 

 

Essential Duties and Responsibilities:

  • Participate in Raw Material Review Board (RMRB as Quality representative to assess raw material supplier driven changes / second source initiatives to develop necessary actions/tasks and determination of change levels. 
  • Engage with R&D and Procurement on project prioritization activities associated with Supplier driven changes and second source initiatives.
  • Collaborate with other West functional areas and drive optimization of raw material change management processes and procedures and bring resolution to issues 
  • Collaborate with global cross functional team to review supplier change notifications and assess impact on West purchased raw material or products. risk assessments for raw material changes.
  • Provide guidance on Raw Material performance and historical data to Quality Operations, as needed.
  • Provide Raw Material/Chemical analysis and consultation as it relates to West’s rubber formulations
  • Prepare and/or review applicable documentation related to raw material change assessments. This includes but not limited to change controls, risk assessments, test methods, and laboratory data.
  • Lead raw material use by date harmonization program; Communicate with impacted cross functional teams on established raw material use by date changes.
  • Review and approve material performance evaluations documentation and data to support changes
  • Serves as the Quality point of contact on assigned projects.
  • Review and/or approve Incoming Raw Material Purchasing Specifications.
  • Lead raw material test specification periodic reviews to ensure accuracy and compliance with applicable procedures.
  • Drive solutions to internal customer raw material related problems/issues and communicate resolutions as needed.
  • Perform and assist with other Quality related responsibilities and duties as assigned
  • Support corporate harmonization initiatives as they pertain to the quality management system.
  • Prepare and Review Procedures as appropriate
  • Utilize knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
  • Execute activities relating to West Quality strategic plans and policies for assigned business unit(s), projects, products and customers.
  • Generate, review, or approve Quality related documentation.

 

Basic Qualifications: 

  • Education: Bachelor’s degree in chemistry or related science preferred or equivalent experience in related discipline.
  • Experience: Minimum 5 – 8  years of quality related experience with preferred experience in pharmaceutical and/or medical device industry. 

 

Preferred Knowledge, Skills and Abilities:

  • Chemistry background with experience in raw material assessments as it relates to rubber formulations
  • Knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
  • Strong knowledge of injectable drugs, containers, devices, and administration technologies.
  • In depth knowledge of technical writing
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
  • Working knowledge of Rubber and or container closure manufacturing processes.
  • Experience with working with suppliers and supplier engagement activities.
  • Experience with SAP system and LIMs
  • Familiarity with document management databases, particularly Master Control
  • Knowledge of continuous improvement principles
  • Demonstrated ability to up skill / coach others

 

Travel Requirements:

  • Minimal travel as required

 

Physical & Mental Requirements:

  • Able to be aware of relevant SOPs as per Company policy as they relate to the position covered by this Job Description
  • Work in an office environment.  At times must sit for extended periods of time.
  • 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.
  • Able to comply with the company’s Quality and Safety policy at all times

 

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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