Quality Assurance Specialist

Job Title:
Quality Assurance (QA) Specialist

The Quality Assurance (QA) Specialist is responsible for supporting and maintaining compliance with Good Laboratory Practice (GLP) regulations, internal SOPs, and applicable regulatory requirements within a preclinical contract research laboratory. This role performs study-based and process-based audits, manages document control and archiving activities, supports sample accountability oversight, assists with equipment validation activities, and contributes to successful client and regulatory inspections. The QA Specialist works cross-functionally with scientific, operations, and management teams to promote data integrity, quality systems effectiveness, and continuous improvement.

• Conduct GLP compliance audits including protocols, amendments, raw data, reports, and inprocess inspections.
• Perform facility, process, and systems audits to verify adherence to SOPs and regulatory requirements (FDA GLP 21 CFR Part 58, OECD GLP).
• Document audit findings clearly and objectively; track responses and corrective/preventive actions (CAPAs).
• Verify protocol compliance and data integrity (ALCOA+ principles).
• Verify proper use of validated systems.
• Contribute to QA statements and study inspection reports.

• Maintain controlled documents including SOPs, forms, templates, and policies.
• Manage document lifecycle processes (creation, review, approval, revision, distribution, archival).
• Ensure proper indexing, retrieval, and retention of study records and raw data.
• Oversee secure and compliant GLP archive operations and record transfers.
• Conduct periodic archive audits and inventory checks.

• Audit sample receipt, labeling, storage, tracking, and disposition processes.
• Verify chain‑of‑custody documentation and sample accountability.
• Ensure storage conditions and environmental monitoring meet protocol and GLP requirements.
• Participate in sample reconciliation and inventory reviews.

• Support validation lifecycle activities (IQ/OQ/PQ), equipment qualification, and computerized system validation (CSV).
• Review validation protocols, reports, and change control documentation.
• Verify calibration and maintenance compliance during audits.
• Assist with deviation, CAPA, and change control processes.

• Assist with preparation and hosting of regulatory inspections and client audits.
• Compile documentation packages and support inspection readiness activities.
• Participate in mock inspections and internal gap assessments.
• Track commitments and responses following inspections.

• Support training compliance tracking and QA metrics.
• Assist in SOP development and quality system improvements.
• Participate in risk assessments and process improvement initiatives.

• Bachelor’s degree in life sciences, quality assurance, or related scientific field required.
• 2–5 years of QA or laboratory experience in a GLP‑regulated environment preferred.
• Experience in preclinical CRO, pharmaceutical, biotechnology, or regulated research setting highly desirable.

• Working knowledge of FDA GLP regulations (21 CFR Part 58), OECD GLP, and data integrity principles (ALCOA+).
• Familiarity with auditing techniques and quality management systems.
• Understanding of document control, archival processes, and equipment validation.
• Strong written communication and technical documentation skills.
• Ability to interact professionally with clients and regulatory inspectors.
• Strong attention to detail and organizational skills.
• Quick turnaround on requests, with accuracy and thoroughness being critical.
• Ability to handle multiple tasks, respond quickly and efficiently, and keep situations under control in a fast‑paced, dynamic work environment.
• Ability to adapt to changing procedures, policies, and work environments.
• Ability to compose clear, concise, and professional written communication.
• Ability to meet deadlines and work under pressure.
• Flexibility and adaptability with…