Senior Data Review Specialist

West Pharmaceutical Services•Uwchlan Township, PA

8d•Hybrid

About The Position

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.

Requirements

Bachelor's Degree in Chemistry or related field, or equivalent experience
Minimum 5 years previous experience in data review, mass spectrometry
Experience in FDA regulated environment, GMP compliance
Strong oral and written communication skills and attention to detail required.

Nice To Haves

Minimum 5 years of cGMP experience and knowledge, preferred
Preferred working knowledge of laboratory testing including methodologies
Preferred knowledge of Compendia requirements a plus
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

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 abides by all regulations, policies, work procedures, instruction, and all safety rules.
Exhibits regular, reliable, punctual and predictable attendance.
Other duties as assigned.