Quality Control Analyst
Core
Conduct routine and non-routine testing for process water, environmental, and compressed gas monitoring, plus cleaning verification for equipment release in a contract API manufacturing facility.
Role type
Quality Control Analyst (Analytical Chemistry)
Builds
Supports manufacturing activities and equipment release for nucleic acid therapeutics.
Domain
Biopharma / Life Sciences / Contract Manufacturing
Required skills
cGMP compliance, FDA regulations, analytical instrumentation (UV, HPLC, HPLC-MS), data review and reporting, troubleshooting, corrective and preventive actions, preventative maintenance coordination, documentation practices
Preferred skills
ChemStation, microbiological testing, raw material testing
Technologies
HPLC, UV Analysis, ChemStation, Microsoft Excel, Microsoft Word
Responsibilities
Conduct analysis for clinical and non-clinical laboratory studies under cGMP; review data for compliance and troubleshoot abnormalities; investigate and resolve laboratory testing failures; ensure equipment performance and coordinate preventative maintenance; exercise judgment in selecting methods and evaluation criteria.
Seniority
Junior, 0-2 years experience
