QC Stability Coordinator

Stability Coordinator – Salt Lake City, UT

Base pay range: $30.00/hr - $40.00/hr

Contract – 12 months, fully onsite.

We are a fast‑growing biotechnology company expanding our team and urgently need a Stability Coordinator to support our QC team from Phase 1 through commercial. The specialist will plan, execute, and maintain cGMP stability programs, handle day‑to‑day stability logistics, generate and maintain stability protocols and trending reports, trend data for critical reagents and assay controls, compile system suitability data, and coordinate cross‑functional activities and timelines.

• 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
  .

• 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.