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Title:  Sr Specialist, Quality

Requisition ID:  62656
Date:  Nov 20, 2023

Exton, Pennsylvania, US

Department:  Quality



Who We Are

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  


There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  


We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

This position is responsible for all stages of receiving customer complaint, interacts with customer for additional information, acting as a liaison with plant QA, TCS, Sales, Order Fulfilment, Data Governance, and other areas necessary to satisfy customer’s expectations. It leads and manages the customer complaint process to ensure that the system is in place and procedure is being followed. Complies customer complaint specific data as needed to support customer’s review meeting in general.


Essential Duties and Responsibilities:

  • Provide support to Quality group ensuring consistent application of procedures in place
  • Manage key projects/initiatives related to customer complaints and ensures that progress is within expected guidelines and timelines.
  • As the point of quality contact when receiving customer complaints, performs a variety of duties such as assembling all information (customer and West), coordinating and managing multidisciplinary technical review teams (Lab, TCS, QS, etc) when necessary for critical complaints
  • Aid initial receipt, review, trending and impact assessments for customer complaint issues
  • Receive and proper handling of customer complaint and compliant samples in the West System
  • Enter customer complaints in SAP.
  • Coordinates and manages day-to-day operations and communications with customer and internal departments/plants to ensure all information is available on time to perform customer complaint investigation
  • Ensure all customer information necessary to initiate the investigation is received and recorded accordingly
  • Facilitate communication between West and customer on complaint critical issues and aid the plant in preparation for the meeting and ensure expectation is aligned
  • Coordinate customer credit for complaints involving return and credit disposition
  • Work with QA sites and Exton Lab personnel to meet target customer satisfaction goals on investigation response time
  • Identify opportunities for improvement on complaint process in general
  • Review complaint data, analyzes results and recommends changes based upon findings. Prepare customer specific complaint data and trend as requested
  • Prepare report by collecting, analyzing and summarizing data, making recommend
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance.
  • Other duties as assigned


Basic Qualifications: 

  • Education: Bachelor’s or equivalent work experience
  • Experience: Minimum 5 years of experience in Quality and/or customer complaint system


Preferred Knowledge, Skills and Abilities:

  • Attention for detail and deadline driven
  • Strong verbal and written communication skills
  • Working familiarity with root cause investigation tools
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • A sense of urgency/initiative
  • Demonstrate team building and problem-solving skills
  • Knowledge of cGMP requirements and ISO standards
  • Ability to effectively prioritize and escalate issues
  • Experience with customer interface and meeting customer expectations


Travel Requirements:

  • Up to 5% travel, minimal


Physical & Mental Requirements:

  • Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
  • Ability to comply with quality and safety policies
  • Ability to effectively communicate and comprehend complex ideas and concepts.
  • Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
  • Position operates in a professional office environment. May stand or 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
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems



West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.  

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