GMP QC Data Integrity Scientist

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

Benefits offered by this job

Competitive salary

Medical insurance

Dental insurance

Vision insurance

401K retirement plan

Life insurance

Disability insurance

Paid time off

HSA

Tuition reimbursement

Employee Assistance program

Parental leave

Job summary

Pace® Analytical Services in Massachusetts is seeking a Scientist to thoroughly review and verify analytical testing data generated in the QC laboratory. You will ensure results are accurate, complete, and compliant with GxP regulations and validated methods.

The role serves as a checkpoint before batch release, managing testing trackers, and overseeing QC workflows. Strong data integrity, regulatory knowledge (ICH Q2(R2), Q10, FDA/EMA) and collaboration with cross-functional teams are essential.

Qualifications

• GMP QC laboratory experience (3–5 years)
• Experience with method validation and risk assessments
• CAPA tracking and change control tracking experience
• Strong organizational, attention to detail, and communication skills
• Proficiency with Office 365 and LIMS

Responsibilities

• Perform first and/or second-level review of raw data, chromatograms, calculations, and test records
• Verify testing followed approved methods, SOPs, and specifications
• Identify discrepancies, anomalies, or data integrity issues and escalate appropriately
• Conduct trend analysis on QC data to detect signals, drifts, or systemic issues
• Support OOS and OOT investigations, Deviations and Change Controls through data review and RCA
• Own and maintain QC testing trackers for sample status, review progress, and batch release timelines
• Track open actions, deviations, CAPAs, and change controls to ensure timely closure
• Manage documentation workflows, ensuring data packages are complete, reviewed, and archived in Veeva
• Support capacity planning by tracking testing volumes and resource utilization
• Apply data integrity principles (ALCOA+) throughout review activities
• Support audits/inspections by providing reviewed data packages and queries
• Maintain knowledge of regulatory requirements (ICH Q2(R2), ICH Q10, FDA, EMA)
• Collaborate with internal/external teams to meet project goals

Skills

Organizational skills

Attention to detail

Communication skills

Multi-project management

Self-motivated

Results-driven

Education

Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related

Tools

Office 365

LIMS

Job description

Pace® Analytical Services in Massachusetts is seeking a Scientist to thoroughly review and verify analytical testing data generated in the QC laboratory. You will ensure results are accurate, complete, and compliant with GxP regulations and validated methods.

The role serves as a checkpoint before batch release, managing testing trackers, and overseeing QC workflows. Strong data integrity, regulatory knowledge (ICH Q2(R2), Q10, FDA/EMA) and collaboration with cross-functional teams are essential.