Experienced GMP Data Reviewer

Reposted 2 Days Ago
Be an Early Applicant
Waltham, MA, USA
In-Office
114K-125K Annually
Mid level
Greentech • Professional Services • Biotech • Pharmaceutical
The Role
Reviews and verifies GMP analytical QC data, chromatograms, calculations, and test records for accuracy, completeness, data integrity, and regulatory compliance. Conducts trend analysis and supports OOS, OOT, deviation, CAPA, and change-control investigations. Maintains QC testing trackers, documentation workflows, and validated repository records while supporting batch release, audits, capacity planning, and cross-functional project timelines.
Summary Generated by Built In

Shift:

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

Are 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: $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.

Skills Required

  • Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
  • 3-5 years of experience in a GMP QC laboratory environment
  • Experience with analytical method validation
  • Experience with risk assessments
  • Experience with CAPA tracking
  • Experience with change control tracking
  • Excellent organizational, attention-to-detail, and communication skills
  • Ability 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

Pace Labs Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Pace Labs and has not been reviewed or approved by Pace Labs.

  • Retirement Support Employer 401(k) match vests immediately, enhancing long‑term savings potential. Plan descriptions emphasize immediate vesting as a differentiator within the benefits package.
  • Leave & Time Off Breadth Paid time off includes holidays, sick time, and vacation, with some postings also noting floating or parental leave. This breadth covers common leave needs across full‑time roles.
  • Wellbeing & Lifestyle Benefits Benefits include HSAs/FSAs, a wellness program, an EAP, and optional legal/ID‑theft coverage. The menu supports health management and everyday life protection beyond core medical.

Pace Labs Insights

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The Company
HQ: Minneapolis, MN
2,890 Employees
Year Founded: 1978

What We Do

Pace® works with organizations of all types, providing the science to ensure our air, water, therapies, and more are safe for use. Learn more about our laboratory services at PACELABS.com.

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