Experienced GMP Data Reviewer
About this role
Shift:
Monday through Friday, 8:00AM - 5:00PMAre 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:
Compensation: $114,000.00 - 125,000.00 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 ID theft.
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 employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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