onsite
Quality Assurance Supervisor - Kelly Services
Software Engineer
Lead a QA team in a pharmaceutical environment, ensuring compliance with GMP and FDA regulations, driving continuous improvement, and overseeing documentation, validation, and root‑cause investigations.
About the role
Key Responsibilities
- Supervise daily QA activities, including batch release, deviation handling, and change control.
- Ensure all processes and products meet GMP and FDA regulatory requirements.
- Lead root‑cause investigations, corrective and preventive actions (CAPA), and drive continuous improvement initiatives.
- Maintain and audit quality documentation, SOPs, and training records for accuracy and compliance.
- Coordinate with cross‑functional teams to support process validation, qualification, and technology transfers.
- Develop and mentor QA staff, fostering a culture of quality and accountability.
Requirements
- Bachelor’s degree in a scientific or engineering discipline with 5+ years of QA experience in a regulated pharmaceutical setting.
- Strong knowledge of GMP, FDA regulations, and quality management systems.
- Proven experience in root‑cause analysis, CAPA, and documentation control.
- Demonstrated leadership and team‑development skills.
- Excellent communication, problem‑solving, and organizational abilities.
Skills
software developmentsystem designproblem solving