Quality Assurance Manager in Rocky Hill

QA Officer - Bioanalytical Laboratory

The QA Officer is responsible for ensuring quality standards and regulatory compliance within a GLP-compliant bioanalytical laboratory. This role supports bioanalytical studies across small and large molecule platforms, including LC-MS/MS and immunochemistry, by auditing laboratory activities, reviewing documentation, and maintaining quality management systems. The position works closely with scientific and operational teams to ensure compliance with GLP, GCP, and applicable regulatory requirements while driving continuous quality improvement.

Key Responsibilities

• Audit bioanalytical studies, including LC-MS/MS-based studies, during method validation, sample analysis, and reporting phases to ensure data integrity, regulatory compliance (GLP/GCP), and adherence to standard operating procedures (SOPs).
• Oversee the execution of mock studies in collaboration with laboratory scientists and analysts; document findings and recommend improvements to SOPs, workflows, and electronic quality management systems (eQMS) and laboratory information management systems (LIMS).
• Participate in the review, development, optimization, and continuous improvement of SOPs and controlled documents as new laboratory capabilities are implemented.
• Support the implementation and validation of integrated eQMS and LIMS platforms, ensuring compliant data management, secure audit trails, and effective sample tracking.
• Review laboratory records, study documentation, investigation reports, deviations, CAPAs, and change controls to verify completeness, accuracy, and compliance with regulatory requirements.

Qualifications

• Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another related scientific discipline, or equivalent experience.
• Minimum of 8 years of quality assurance experience in a regulated laboratory environment (GLP, GCP, and/or GMP).
• Experience auditing LC-MS/MS workflows and bioanalytical studies.
• Knowledge of bioanalytical method development, method validation, biological sample analysis, and applicable regulatory guidelines, including FDA, EMA, and ICH M10.
• Experience with eQMS and LIMS implementation, validation, and maintenance in a laboratory environment.