Quality Specialist II
Core
Perform chemical and biological testing on raw materials and finished products, review batch records, and support product release in a manufacturing environment.
Role type
Quality Specialist (Quality Control & Assurance)
Builds
Peptones and specialty chemicals for bioproduction and culture media
Domain
Life Sciences / Biotechnology / Manufacturing
Required skills
Laboratory testing, GMP compliance, batch record review, SOP creation, environmental monitoring, analytical methods (pH, bioburden, titration), equipment operation
Preferred skills
Pharmaceutical/biotech industry experience, ERP systems, CAPA, training management software
Technologies
Microsoft Office, ERP systems, electronic document control
Responsibilities
Perform chemical and biological testing on raw materials and finished products, Review manufacturing batch records and quality documentation, Support timely product release and prepare Certificates of Analysis, Create and update standard operating procedures (SOPs), Participate in validation activities and support internal/external audits, Coordinate environmental monitoring and laboratory readiness
Seniority
Entry-level to Mid-level