Experienced GMP Analytical Scienist

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

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: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 yearThe 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 offerResponsibilities:Perform first and/or second-level review of raw data, chromatograms, calculations, and test records generated from analytical testing activitiesVerify that testing was conducted in accordance with approved methods, SOPs, and specificationsIdentify discrepancies, anomalies, or data integrity issues and escalate appropriatelyConduct trend analysis on QC data (including assay controls and reference standards) to detect signals, drifts, or systemic issuesSupport 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 activitiesTrack open actions, deviations, CAPAs, and change controls to ensure timely closure and escalate overdue itemsManage documentation workflows, ensuring data packages are complete, reviewed, and archived in a validated data repository system (Veeva) in a timely mannerSupport capacity planning by tracking testing volumes, resource utilization, and turnaround timesApply data integrity principles (ALCOA+) throughout all review activitiesSupport internal and external audits/inspections by providing reviewed data packages and responding to data-related queriesMaintain 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 timelinesRequirements:Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific disciplineMinimum 3-5 years of experience in a GMP QC laboratory environmentExperience with method validation, risk assessments, CAPA tracking, and change control trackingExcellent organizational, attention to detail, and communication skills.Able to handle multiple projects concurrently, self-motivated, and results drivenProficiency in Office 365, LIMS, and other softwareExperience with mRNA, biologics, or small molecule analytical methods is a plusFind Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.BenefitsWhen 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 EmployerPace 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.