Sr Associate Quality Control I
Core
Support ANC QC Sample Management and Stability operations, including site start-up, sample handling, and stability program delivery for biopharmaceutical drug substances and intermediates.
Role type
Associate Quality Control (QC) Specialist
Builds
Stability studies, QC sample management workflows, and laboratory readiness for clinical and commercial medicines.
Domain
Biopharmaceutical manufacturing and quality assurance
Required skills
Sample management, stability operations, LIMS data entry, SOP preparation, equipment operation, cGMP compliance, documentation control, issue escalation, vendor coordination
Preferred skills
Analytical testing, aseptic technique, technical writing, method validation, change control, team mentoring
Technologies
LIMS, LMES, CIMS, Veeva, TrackWise, Smartsheet
Responsibilities
Receive, track, store, and dispose of QC samples; coordinate stability requests and study starts; maintain storage conditions and backup chamber readiness; support lab start-up, equipment qualification, and validation; perform routine QC testing and data review; prepare reports and qualification summaries; support audits and investigations.
Seniority
Associate, hands-on IC with minimal supervision