Quality Assurance Specialist/Manager - Bioanalytical Laboratory

Job DescriptionJob DescriptionLocation: On-site | Employment Type: Full-time 

We are seeking an experienced, detail-oriented, and proactive Quality Assurance (QA) Specialist or Manager with a strong background in auditing regulated bioanalytical LC-MS/MS and ELISA studies. The ideal candidate will have extensive experience managing internal quality systems and ensuring compliance with regulatory guidelines. A minimum of 3 years of experience in a bioanalytical laboratory environment is required, along with a comprehensive understanding of FDA regulations and other global regulatory requirements governing regulated studies. 

 

Key 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. 

Qualifications: 

• 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. 
• Familiarity with Watson LIMS or similar bioanalytical LIMS software is . 
• 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.