Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support the Client Quality Assurance program, ensuring that pharmaceutical drug substance manufacturing, testing, storage, and distribution meet cGMP, cGLP, and regulatory standards. Working with minimal supervision, the specialist will lead investigations, audits, and cross‑functional projects.

Key responsibilities

• Review and approve product master files, process validation protocols, and environmental characterization reports.
• Lead incident triage, NC investigations, CAPA records, and change control processes.
• Release sanitary utility systems, approve lot disposition, and authorize shipments.
• Represent QA on New Product Introduction (NPI) teams and act as designee for the QA manager on local CCRB.
• Conduct site audits, own site quality program procedures, and support automation, facilities, and environmental programs.
• Review risk assessments, work orders, EMS/BMS alarms, and ensure compliance with regulatory agencies.

Required profile

• Doctorate, Master’s (2 + years experience), Bachelor’s (4 + years experience), Associate’s (8 + years experience), or High School/GED (10 + years experience) in Life Sciences or related field.
• Strong project management, organizational, and cross‑functional leadership abilities.
• Excellent written and oral communication, presentation, and facilitation skills.

Required skills

• cGMP and cGLP compliance knowledge.
• Process validation and change control expertise.
• Risk assessment and CAPA management.
• Automation and data trending/evaluation.
• Experience with EMS/BMS alarm review.

What we offer

• Opportunity to work on critical pharmaceutical quality initiatives.
• Collaborative environment with cross‑functional teams.
• Professional development in regulatory and quality domains.