Quality Control Analyst
Core
Conduct routine and non-routine analysis and review of in-process samples, raw materials, and other requested testing to support in-process testing per SOPs and Analytical Methods in accordance with cGMPs and regulatory requirements.
Role type
Quality Control Analyst
Builds
Nucleic acid therapeutics for life-changing, lifesaving medicines
Domain
Biopharma / Analytical Chemistry
Required skills
Analytical chemistry, cGMP compliance, FDA regulations, data review and troubleshooting, equipment maintenance, documentation practices, judgment in method selection
Preferred skills
Chemstation, UV analysis, HPLC, HPLC-MS, microbiological testing, handling highly potent API material
Technologies
Chemstation, UV, HPLC, HPLC-MS, Microsoft Word, Microsoft Excel
Responsibilities
Conduct analysis on in-process samples, raw materials, and other requested testing; Review data for compliance to specifications and troubleshoot abnormalities; Ensure equipment is performing well and take appropriate action; Follow good documentation practices; Engage in continuous improvement of processes and procedures; Escalate issues to QC management when necessary
Seniority
Mid-level, hands-on IC