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Title:  Sr Specialist Quality

Requisition ID:  60239
Date:  Mar 4, 2023

Exton, Pennsylvania, US

Department:  Quality



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:

Coordinates resolutions to customer complaints, acting as a liaison with plant QA, TCS, Sales, and other groups necessary to satisfy customer requests. Compiles customer specific complaint data as needed. Elaborates key Quality reports, KPIs and customer complaints information to  Management, evaluates data and trending and provides recommendations for improvements, coordinates and updates projects in general by interacting with West sites and functional areas globally. Supports the Quality team & initiatives to improve quality of products and meet customer expectations.


Essential Duties and Responsibilities:

  • Perform assessment and entry of customer complaints for the West U.S. Containment Systems plants
  • Aid in receipt and submission of customer complaint samples to the Exton Laboratory for testing
  • Facilitate communications between West and customer on complaint in general
  • Aid in identification of complaint process efficiencies and identifying customer expectations
  • Coordinate customer credits for complaints associated with the return or destruction of product
  • Develop, prepare, trend, analyze, and report customer complaint metrics to Quality, Sales, TCS, etc. on both periodic and as needed basis
  • Lead and manage key projects/initiatives/objectives related to Quality and ensures that progress is within expected guidelines and timelines
  • Create a detailed work plan which identifies and sequences the activities needed to successfully complete a project.
  • Maintain periodic objective status meetings with plant QA Managers and other support groups
  • Prepare monthly Quality KPI / metric reports for QA Management and find resolution for discrepancies
  • Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
  • Provide instruction and support to the North American plants involved with YBB testing for West’s registration of products with the Chinese NMPA
  • Support plant with performing customer complaint investigations when required
  • Provide support to the project team tasked with defining the processes, responsibilities, and requirements for managing external warehouses and distribution centers
  • Perform the Quality review and approval of new product molds for the Exton Metrology Lab
  • Provide technical and management advice and assistance to department management and personnel when required
  • Identify and determine quality improvement
  • Perform other duties as assigned



Basic Qualifications: 

  • Education: Bachelor’s degree (BS in Science or Engineering preferred)
  • Experience: Minimum of 5 years of experience in Quality Assurance or Operations


Preferred Knowledge, Skills and Abilities:

  • Strong verbal and written communication skills
  • Attention for detail and deadline driven
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • Demonstrate team building and problem solving skills
  • Knowledge of GMP requirements and ISO standards
  • Working knowledge of SAP and experience with MS Office applications (i.e., Excel, Word, PowerPoint, etc.)
  • Strong statistical knowledge and data analysis
  • Ability to effectively prioritize and escalate issues
  • Excellent implementation and customer service skills
  • Able to be aware of all relevant procedures as per Company policy as they are related to the position covered by this Job Description


Travel Requirements:

  • Minimal travel required


Physical & Mental Requirements:

  • Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
  • Use written and oral communication 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








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  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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