NovaBioAssays · 3 weeks ago
Quality Assurance Specialist/Manager – Bioanalytical Laboratory
Woburn, MA
Full-time
Onsite
Mid, Senior Level
3+ years expNovaBioAssays is seeking an experienced Quality Assurance Specialist or Manager with a strong background in bioanalytical laboratory compliance. The role involves ensuring adherence to regulatory guidelines, conducting audits, and providing training to staff on quality assurance practices.
Information Technology
Responsibilities
Ensure compliance of the laboratory’s bioanalytical studies with FDA 21 CFR Part 58 (GLP), Part 320, Part 312, and Part 11 (Electronic Records), as applicable
Review Good Clinical Laboratory Practice (GCLP) compliance for computerized system validations, equipment maintenance, and calibration records
Host regulatory agencies, sponsors, and potential clients; lead audit and inspection response activities
Review study protocols, bioanalytical methods, and reports to ensure adherence to regulatory standards and the accuracy, completeness, and reliability of data
Conduct audits of bioanalytical studies for compliance with FDA regulations, GLP, GCP, and applicable guidelines (e.g., EMA, ICH, ISO)
Verify that study documentation (e.g., batch records, raw data, final reports) meets regulatory requirements for data integrity, traceability, and transparency
Prepare detailed audit reports, identifying non-conformances, deviations, and opportunities for improvement
Perform and document facility inspections; monitor laboratory activities against SOPs, validation plans, protocols, and regulatory guidelines
Evaluate laboratory procedures, records, and data for alignment with industry and regulatory standards
Collaborate with laboratory management to review audit findings and implement corrective and preventive actions (CAPAs)
Track CAPA implementation and assess effectiveness to ensure timely resolution of audit findings
Provide training and guidance to laboratory staff on GLP, GCP, and regulatory requirements for LC-MS/MS and ELISA assays
Author, review, and maintain SOPs, report templates, training plans, regulatory refresher training materials, and trending reports
Stay informed on updates to regulatory guidelines and communicate changes to the team
Qualification
Required
Bachelor's degree (for Specialist) or Master's degree (for Manager) in Life Sciences, Chemistry, Biochemistry, or a related field
Minimum of 3 years (Specialist) or 5 years (Manager) of experience in a bioanalytical laboratory QA or auditing role focused on regulated studies
Strong understanding of FDA regulations (21 CFR Parts 58, 312, 320, 11), GLP, GCP, and relevant standards (e.g., ISO, ICH)
Hands-on experience with Sciex mass spectrometers and Analyst/OS software, or ELISA, MSD, and qPCR platforms is a strong advantage
Proven experience auditing regulated studies in bioanalysis, clinical trials, or pharmaceutical development
Deep understanding of regulatory requirements for bioanalytical testing, particularly LC-MS/MS and ELISA
Knowledge of data integrity, laboratory documentation practices, and quality control systems
Excellent written and verbal communication skills, with the ability to clearly document findings and recommendations
High attention to detail and the ability to critically evaluate complex data and documentation
Preferred
Familiarity with Watson LIMS or similar bioanalytical LIMS software
Benefits
401(k)
401(k) matching
Bonus based on performance
Dental insurance
Health insurance
Paid time off
Company
NovaBioAssays
NovaBioAssays LLC is a Greater Boston-based contract research organization.
11-50 employees
H1B Sponsorship
NovaBioAssays has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Early StageCompany data provided by crunchbase