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.

• 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.

Associate

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