Associate specialist

Associate Specialist, Metrology

Requisition ID:

71975

Date:

Oct 30, 2025

Location:

Exton, Pennsylvania, US

Department:

Laboratory

Description:

This is an onsite position requiring the team member to be onsite 5 days a week.

No relocation is provided for this opportunity

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 role, you will be responsible for providing support for maintaining the instrument quality program including the creation of validation documents. The Associate Specialist must work with Lab Operations, D&T, and Quality Assurance to assure compliance with processes and procedures to reduce risk and improve compliance and productivity.

Essential Duties and Responsibilities

• Responsible for data review and instrument qualification review per GDP requirements

• Responsible for data input into SAP (instrument calibration management system)

• Responsible for creation of documentation and revisions of documents to support and maintain the quality management system for laboratory instruments

• Support and maintain the instrument quality program including annual installation qualifications, preventative maintenance documentation, and instrument asset life cycle management

• Support and collaborate with lab employees, onsite contractors and outside vendors for repair and installation of lab equipment

• Provide input and support to maintain the project schedules and activities for new installation projects. This includes creating instrument validation plans and change controls for new installation

• Writing and conducting laboratory investigations and deviations

• Writing and reviewing work instructions and procedures

• Must keep current with new technologies and cGMP regulations

• Support the lab Metrology group with other activities and projects as needed

• Perform follow-up activities for metrology areas of work

• Responsible for Metrology purchasing and inventory of consumable instrument parts, and assuring compliance with the approved supplier list

• Other duties as assigned.

Education

• Bachelor's degree in related area

Work Experience

• Minimum 1 year experience in cGMP pharmaceutical industry

• 0-1 year experience with GDP

Preferred Knowledge, Skills and Abilities

• Understanding of a cGMP environment

• Experience with Quality Management Systems and good documentation practices

• Excellent problem-solving skills and root cause analysis

• Understanding of regulatory guidelines such as Z540, ISO 9001, ISO 17025 and cGMP

• 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

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

Additional Requirements

• 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

• 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, prioritize and work under deadlines with constant interruptions

• Ability to make independent and sound judgments

• Observe and interpret situations, analyze and problem solve

• Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes

• Learn and apply new information and new skills

1st Shift

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 [email protected] . 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.