Jobs and Careers

Senior Specialist, Analytical Review

Exton, PA, US, 19341, United Statesfull_timeVerifiedPosted 14 May 2026

About the role

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship 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 to independently provide review of analytical data generated for all internal and external customers. This position will focus on the review of data from the Extractables group which includes GC/MS, LC/MS, and ICPMS analysis. This position also requires maintaining knowledge of the current US and International regulations/guidelines/policies applicable to West’s products and services. Serve as a Subject Matter expert by providing technical support regarding documentation and data integrity with the Laboratory. Mentor others and provide technical direction.

Essential Duties and Responsibilities

Perform cGMP and technical Data Review on the analytical data generated in Lab Operations primarily for the Extractables group. This includes review primarily on GC/MS, LC/MS, and ICP/MS techniques.
Perform review as needed in other areas of data review. This may include raw materials and finished goods, product performance, container closure integrity, leachables/extractables, particle analysis, stability, and/or microscopy/investigation.
Be an expert on interpretation on various techniques available in the laboratory specifically mass spectrometry but also including but not limited to chromatography, CCI testing,USP/EP/JP/YBB Compendia Testing, ISO Testing, Instron and Zwick, ICP, ICPMS, DSC, TGA, IR, UV,AA.
Review the analytical raw data generated by first and second shift laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance.
Review Electronic Data and Audit Trails for Data Integrity compliance.
Support new GMP compliance guidance and data integrity initiatives.
Collaborate with Laboratory Services, Project Management and Integrated Solutions.
Maintain working knowledge of computer software packages including MS Office suite, Adobe, Master Control, LIMS, Empower and LMS.
Collaborate with analysts on proposed path forward regarding documentation questions.
Review Internal and External Client Reports generated from Lab Operations from multiple analysts utilizing multiple techniques for cGMP compliance and Data Integrity.
Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance.
Manage projects from Protocol to final report.
Willingness to work with Project Management and Lab Operations in lab study designs and preparation of study protocols and meeting expected time lines involving constant prioritization and staying informed of changes that come along.
Authoring of Work Instructions, where appropriate.
Review and assist in the preparation of Work Instructions, Preformatted Notebooks, and Forms for Lab Operations.
Train Data Reviewers and Supervisors and Analysts on Analytical data review and data integrity, as appropriate
Keep current with new GMP compliance guidance and internal QA procedures.
Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
Willingness to learn new and review new analytical techniques.
Mentor others and provide technical direction.
Provide leadership for cGMP compliance and technical training. Serve as a role model for positive leadership.
Meet individual and departmental goals as required
Conforms with and a