Experienced GMP Analytical Scienist

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

Shift

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

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 elevate 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 elevate 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.