Experienced GMP Analytical Scientist

Shift: Monday through Friday, 8:00AM - 5:00

PMAre you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

Description:

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.

Compensation: $ -  per year

The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate’s geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer

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

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

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

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and .Equal

Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of…