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 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.
Numbers & Facts
| Location | Waltham, Massachusetts |
| Industry | Other/Not Classified |
| Company Size | 2,500 to 4,999 employees |
| Year Founded | 1978 |
| Website | https://www.pacelabs.com/ |
About Company
Three divisions. Two countries. 1800 employees. Twenty-eight environmental labs. Two Life Sciences labs. Twenty-four service centers. Hundreds of certifications. 38 years of industry experience. Financial stability. Dynamic thought leadership and strategic management planning with one shared vision: work together to protect our environment and improve our health.
Pace began on a much smaller scale in 1978, serving Minneapolis and the surrounding areas with founder and CEO Steve Vanderboom at the helm. A commitment to safety and high ethical standards, respect for both clients and employees, and a drive for excellence inspired us as we expanded - and these values are at the core of everything we do today. Still under Vanderboom's directorship, we are proud to be industry leaders, offering an unparalleled range of services delivered by the most experienced scientific professionals. No matter the scope of work or special requirements, we have the people, knowledge and technology to tackle them. Partnering with us, clients are guaranteed to experience the Pace Analytical difference.
Pace Analytical Services, LLC. provides analytical services including environmental testing and sampling. Laboratories utilize EPA, ASTM Standard Methods, NIOSH and other accepted test procedures and methods in accordance with both federal and state regulations. Pace also provides specialty analytical support for air toxics, aquatic toxicity, bioassay, biota, dioxin/furans, low-level mercury, radiochemistry, vapor intrusion, environmental forensics, industrial hygiene, etc.
Pace Analytical Life Sciences provides analytical testing services to the pharmaceutical/medical device industries. Services include chemical and microbiology, method development/validation, physical testing, raw material testing, stability testing and storage, and product release testing. Pace operates two FDA-registered, DEA-registered (Class I - V), cGMP-compliant facilities: one located in Oakdale, MN and the other located in San German, PR. The Oakdale, MN facility is ISO/IEC 17025:2005 accredited.
Pace Analytical Lab Ops Division provides professional scientific staffing - to accommodate full outsourcing or augmentation of staff at a client's on-site location - to various industries as well as research and development organizations. The ISO 9001:2008 certified Lab Ops Division also provides instrumentation sales, repair and qualification services, product and materials testing support and regulatory compliance services.
Pace began on a much smaller scale in 1978, serving Minneapolis and the surrounding areas with founder and CEO Steve Vanderboom at the helm. A commitment to safety and high ethical standards, respect for both clients and employees, and a drive for excellence inspired us as we expanded - and these values are at the core of everything we do today. Still under Vanderboom's directorship, we are proud to be industry leaders, offering an unparalleled range of services delivered by the most experienced scientific professionals. No matter the scope of work or special requirements, we have the people, knowledge and technology to tackle them. Partnering with us, clients are guaranteed to experience the Pace Analytical difference.
Pace Analytical Services, LLC. provides analytical services including environmental testing and sampling. Laboratories utilize EPA, ASTM Standard Methods, NIOSH and other accepted test procedures and methods in accordance with both federal and state regulations. Pace also provides specialty analytical support for air toxics, aquatic toxicity, bioassay, biota, dioxin/furans, low-level mercury, radiochemistry, vapor intrusion, environmental forensics, industrial hygiene, etc.
Pace Analytical Life Sciences provides analytical testing services to the pharmaceutical/medical device industries. Services include chemical and microbiology, method development/validation, physical testing, raw material testing, stability testing and storage, and product release testing. Pace operates two FDA-registered, DEA-registered (Class I - V), cGMP-compliant facilities: one located in Oakdale, MN and the other located in San German, PR. The Oakdale, MN facility is ISO/IEC 17025:2005 accredited.
Pace Analytical Lab Ops Division provides professional scientific staffing - to accommodate full outsourcing or augmentation of staff at a client's on-site location - to various industries as well as research and development organizations. The ISO 9001:2008 certified Lab Ops Division also provides instrumentation sales, repair and qualification services, product and materials testing support and regulatory compliance services.
Skills
- Analysis Skillsunmatched
- Assaysunmatched
- Biochemistryunmatched
- Biotech and Pharmaceuticalunmatched
- Budgetingunmatched
- Capacity Managementunmatched
- Change Controlunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Data Analysisunmatched
- Data Qualityunmatched
- Detail Orientedunmatched
- Document Managementunmatched
- External Auditunmatched
- GMP (Good Manufacturing Practices)unmatched
- GxPunmatched
- Internal Auditunmatched
- Laboratory Testingunmatched
- Multitaskingunmatched
- Organizational Skillsunmatched
- Process Improvementunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Resource Utilizationunmatched
- Risk Analysisunmatched
- Root Cause Analysisunmatched
- Safety/Work Safetyunmatched
- Small Moleculesunmatched
- Standard Operating Procedures (SOP)unmatched
- System Validationunmatched
- Test Dataunmatched
- Testingunmatched
- Time Managementunmatched
- Trend Analysisunmatched
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder