Quality Assurance Specialist
Core
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes.
Role type
Quality Assurance Specialist (Manufacturing/Pharma)
Builds
Healthcare solutions (medicines and vaccines)
Domain
Biopharma / Healthcare Manufacturing
Required skills
cGMP compliance auditing, incident investigation, CAPA management, change control assessment, SOP review, sampling techniques (AQL/Parallel/CCA), aseptic processing area monitoring, risk assessment, regulatory documentation review
Preferred skills
Data analysis for trend identification, project management, complex problem solving
Technologies
None stated
Responsibilities
Conduct cGMP audits within functional areas; perform parallel and CCA sampling; complete risk assessment and incident investigations; manage the CAPA system; review SOPs and Master Manufacturing Records; provide daily floor coverage for compliance in aseptic and testing areas; interact with internal/external auditing bodies.
Seniority
Mid-level (3+ years experience preferred)
