What are the responsibilities and job description for the Quality Control Technician position at Redbock - an NES Fircroft company?
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 <1116> 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 <1225>, <621>) 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 <1116>), utilities monitoring, and EM dashboards are advantageous but not required.