Title: Specialist, Quality Systems

Requisition ID: 68716

Date: Mar 12, 2025

Location:

Exton, Pennsylvania, US

Department: Quality

Description:

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

In this global role, you will support Quality Systems functions which may include one or more of the following: Audit, global and local Document Control, Change Control and Notification, Training/LMS, CAPA, and Specifications. The role will ensure compliance to West Quality Management System procedures and protocols as well as applicable regulations and standards. In this global role, you will drive the improvement of quality systems across West.

Essential Duties and Responsibilities

Maintain records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
Use MasterControl as an administrator/Sub-Admin/SME
Capture and maintain metrics, including trending and analysis, on relevant processes and report performance to management.
Engage with and support cross functional teams on quality improvement projects, change management, CAPA, specification management, training etc.
Support and provide guidance to West’s internal and external customers as needed with QMS related requests and questions.
Support corporate harmonization initiatives as they pertain to the quality management system.
As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
Participate in quality audits (Internal and External) as needed either as part of audit team or supporting backroom activities.
Ability to work independently with a moderate level of guidance and direction.
Other duties as assigned.

Education

Bachelor's Degree in Science preferred or equivalent experience in related discipline

Work Experience

Minimum 3 years Quality related experience with preferred experience in Medical Device / pharmaceutical industry.
Experience with SAP systems preferred
Experience with MasterControl preferred

Preferred Knowledge, Skills and Abilities

In depth knowledge of cGMP, cGDP, 21CFR820, relevant ISO standards (9001, 15378, 13485)
Familiarity with electronic document management databases, particularly MasterControl.
Able to comply with the company’s safety policy at all times
Able to comply with the company’s quality policy at all times

Additional Requirements

Excellent oral and written communication and interpersonal skills
Organizational skills that will enable planning, prioritization & achievement of goals
Observe and interpret situations, analyze possible solutions, and solve problems with a moderate level of guidance.
Must maintain the ability to work well with others in a variety of situations and at varying organizational levels in the business
Must be able to multi-task and work under time constraints
Ability to make independent and sound judgments
Ability to follow procedures

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. 