Bioanalytical QA Lead — GLP/GCP Compliance

Kelly Science, Engineering, Technology & Telecom; Montgomery Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom in New Jersey seeks a QA Officer to ensure GLP-compliant quality across bioanalytical studies, including LC-MS/MS and immunochemistry, by auditing activities, reviewing documentation, and maintaining the quality management system.

Collaborating with scientists and operations, you will ensure compliance with GLP, GCP, and GMP guidelines and drive continuous improvement through SOP enhancements, eQMS and LIMS implementation, and thorough record

Qualifications

• Bachelor's degree or higher in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences, or related field.
• Minimum 8 years of QA 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, validation, and regulatory guidelines (FDA, EMA, ICH M10).
• Experience with eQMS and LIMS implementation, validation, and maintenance in a laboratory environment.

Responsibilities

• Audit bioanalytical studies for data integrity and regulatory compliance (GLP/GCP).
• Oversee mock studies and document findings; improve SOPs, workflows, eQMS, and LIMS.
• Participate in development and continuous improvement of SOPs and controlled documents as new capabilities are implemented.
• Support the implementation and validation of integrated eQMS and LIMS platforms, ensuring compliant data management and secure audit trails.
• Review laboratory records, study documentation, investigation reports, deviations, CAPAs, and change controls for completeness and accuracy.

Skills

Audit processes

Regulatory compliance

Documentation review

Bioanalytical methods knowledge

Education

Bachelor's degree or higher in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences or related field

Tools

eQMS

LIMS

Job description

Job Description: QA Officer – Bioanalytical Laboratory

Position Summary

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.