Quality Control Technician

Stability Coordinator A fast-growing biotechnology company is expanding their team in Salt Lake City, and they are in immediate need of a Stability Coordinator to support them fully onsite for 12 months . This specialist will support the QC team by planning, executing, and maintaining cGMP stability programs from Phase 1 through Commercial. Depending on team needs, this role may also support Environmental Monitoring (EM) trending in partnership with QC Microbiology, including compiling and evaluating EM data to meet Annex 1/USP expectations. The ideal candidate is detail‑oriented, comfortable with cGMP documentation, and skilled at coordinating cross‑functional activities and timelines. Key Responsibilities Draft, route, and maintain stability protocols/amendments per SOPs and ICH Q1A–Q1F . Plan and stage studies ( sample plans, labeling, chamber placement ) and ensure required chamber monitoring. Own the master stability calendar ; schedule pulls and testing across Phase 1 to Commercial. Coordinate sample handling/shipments to internal and partner labs; maintain chain‑of‑custody and inventory accuracy. Compile data/certificates and issue periodic stability trending reports for internal review and filings. Trend critical reagents/assay controls ; maintain control charts; recommend replenishment or expiry extensions. Consolidate method system‑suitability results; set/track assessment due dates; escalate risks and propose mitigations. Ensure ALCOA+ and GDP principles are applied in protocols, worksheets, LIMS entries, and reports. Support stability‑related deviations, OOS/OOT trending, change controls, and CAPAs ; maintain stability SOPs/forms/templates. Enter/track studies in LIMS/ELN ; use CDS/statistical tools (e.g., Empower, Excel/JMP); coordinate with CROs/CDMOs . Qualifications BS/BA in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (or equivalent experience) with 2+ years in cGMP QC/stability/analytical operations. Strong working knowledge of ICH Q1A–Q1F, cGMP/GDP, data‑integrity principles Proficiency with LIMS/ELN and spreadsheet/statistical tools (e.g., Excel/JMP); exposure to Empower or other CDS a plus. Excellent organization/communication skills with the ability to manage multiple products/time points and coordinate across internal teams and CROs/CDMOs. Familiarity with biologics and cold‑chain/accelerated stability; understanding of method‑validation concepts (e.g., USP , ) and APR/PQR inputs; awareness of critical‑reagent lifecycle/trending. Experience supporting GMP testing/equipment qualification, Empower CDS or equivalent, and commercial readiness/start‑up activities. EM/cleanroom knowledge (Annex 1/USP ), utilities monitoring, and EM dashboards are advantageous but not required. Seniority level Associate Employment type Contract Job function Product Management #J-18808-Ljbffr