Experienced GMP Analytical Scienist

Pace Analytical Services•Waltham, MA

13d•Onsite

About The Position

The Scientist is responsible for the thorough review and verification of analytical testing data generated in the QC laboratory. This role ensures all test results are accurate, complete, and compliant with GxP regulations, approved CMC dossiers and validated methods and SOPs. The incumbent serves as a critical checkpoint between data generation and batch release decisions, while also managing testing trackers and overseeing QC operational workflows.

Requirements

Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
Minimum 3-5 years of experience in a GMP QC laboratory environment
Experience with method validation, risk assessments, CAPA tracking, and change control tracking
Excellent organizational, attention to detail, and communication skills.
Able to handle multiple projects concurrently, self-motivated, and results driven
Proficiency in Office 365, LIMS, and other software

Nice To Haves

Experience with mRNA, biologics, or small molecule analytical methods is a plus

Responsibilities

Perform first and/or second-level review of raw data, chromatograms, calculations, and test records generated from analytical testing activities
Verify that testing was conducted in accordance with approved methods, SOPs, and specifications
Identify discrepancies, anomalies, or data integrity issues and escalate appropriately
Conduct trend analysis on QC data (including assay controls and reference standards) to detect signals, drifts, or systemic issues
Support and own Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, Deviations and Change Controls through data review and root cause analysis (RCA)
Own and maintain QC testing trackers (sample status, review progress, batch release timelines) to ensure full visibility of testing activities
Track open actions, deviations, CAPAs, and change controls to ensure timely closure and escalate overdue items
Manage documentation workflows, ensuring data packages are complete, reviewed, and archived in a validated data repository system (Veeva) in a timely manner
Support capacity planning by tracking testing volumes, resource utilization, and turnaround times
Apply data integrity principles (ALCOA+) throughout all review activities
Support internal and external audits/inspections by providing reviewed data packages and responding to data-related queries
Maintain up-to-date knowledge of regulatory requirements (ICH Q2(R2), ICH Q10, FDA, EMA guidelines)
Collaborate with internal and external teams to support project goals and meet research timelines