QC Operations Support Associate
Core
Provides essential GMP QC support in a highly regulated Annex 1 aseptic manufacturing facility, ensuring compliant execution of line clearance, environmental monitoring, water sampling, and batch record review.
Role type
QC Operations Support Associate
Builds
sterile medicinal products
Domain
Life sciences / Pharmaceutical manufacturing
Required skills
GMP compliance, aseptic techniques, environmental monitoring, batch record review, root cause analysis, CAPA management, data integrity (ALCOA+), audit readiness
Preferred skills
Engineering or Science degree, extensive related experience
Technologies
None stated
Responsibilities
Execute line clearance and aseptic readiness checks; perform viable and non-viable environmental monitoring in Grade C & D areas; conduct aseptic sampling of Purified Water, Water for Injection, and Clean Steam; review batch records and process logbooks; support EM investigations and CAPA; author and update processes for compliance; manage incident reports and non-conformances.
Seniority
Individual Contributor
