QC Data Analyst
Core
Compile, trend, and report product release data to prepare Certificates of Analysis (CoAs) and Summaries of Analysis (SoAs) supporting lot release and regulatory filings.
Role type
Associate QC Data Analyst
Builds
Certificates of Analysis (CoAs), Summaries of Analysis (SoAs), and trending reports for product release
Domain
Pharmaceutical Quality Control / cGMP
Deliverable
dashboards & analysis
Required skills
Data compilation, Trend analysis, Report writing, SOP maintenance, cGMP compliance, Cross-functional collaboration
Preferred skills
cGMP pharmaceutical laboratory experience
Technologies
None explicitly stated
Responsibilities
Compile internal and external data to prepare CoAs and SoAs for lot release, Trend QC product release data to support regulatory filings, Write annual product and lot-specific release data trending reports, Partner with Manufacturing, QA, RA, R&D and PAS for investigations and validation studies, Build and maintain tracking matrices and QC metrics for release and stability testing, Maintain and update SOPs for data review and reporting, Meet specified timelines for lot release and regulatory filings
