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. 

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 preferred. 

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.