GMP QC Data Review Scientist

Pace Analytical Services LLC; Waltham (MA); On-site; USD 114,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision

401K retirement plan

Paid time off

HSA

Tuition reimbursement

Employee Assistance program

Parental leave

Job summary

Pace Analytical Services LLC is hiring a Scientist to thoroughly review analytical testing data in the QC laboratory, ensuring results are accurate, complete, and compliant with GxP regulations and validated methods.

This role serves as a critical checkpoint between data generation and batch release, while also managing testing trackers and supporting QA investigations. A 3–5 year GMP QC background is expected, with proficiency in Office 365, LIMS, and Veeva.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 3–5 years of GMP QC laboratory experience.
• Experience with method validation, risk assessments, CAPA tracking, and change control tracking.
• Proficiency in Office 365, LIMS, and other software.
• 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.
• Verify testing was conducted per approved methods, SOPs, and specifications.
• Identify discrepancies, anomalies, or data integrity issues and escalate.
• Conduct trend analysis on QC data to detect signals or drift.
• Support OOS and OOT investigations, deviations and change controls.
• Own and maintain QC testing trackers to ensure visibility of activities.
• Manage documentation workflows and archiving in a validated data repository (Veeva).
• Support audits/inspections with reviewed data packages and queries.

Skills

Data review

Data integrity

Regulatory compliance

Analytical thinking

Communication

Education

Bachelor’s in Chemistry/Biochemistry/Pharmaceutical Sciences

Master’s degree (preferred)

Tools

Office 365

LIMS

Veeva

Job description

Pace Analytical Services LLC is hiring a Scientist to thoroughly review analytical testing data in the QC laboratory, ensuring results are accurate, complete, and compliant with GxP regulations and validated methods.

This role serves as a critical checkpoint between data generation and batch release, while also managing testing trackers and supporting QA investigations. A 3–5 year GMP QC background is expected, with proficiency in Office 365, LIMS, and Veeva.