Quality Control Technician

Redbock - an NES Fircroft company; Salt Lake City (UT); On-site; USD 60,000 - 80,000; Full time

Job summary

A fast-growing biotechnology firm in Salt Lake City is seeking a Stability Coordinator to manage cGMP stability programs for a 12-month contract. This role supports the QC team, ensuring compliance with regulations and effective data management. Candidates should possess a Bachelor’s degree in a relevant field and have at least 2 years of relevant experience. Strong organizational and communication skills are critical. The position involves extensive partnership with internal teams and external organizations to meet quality assurance goals.

Qualifications

• 2+ years in cGMP QC/stability/analytical operations required.
• Familiarity with biologics and cold-chain/accelerated stability is advantageous.
• Experience supporting GMP testing/equipment qualification is a plus.

Responsibilities

• Draft and maintain stability protocols per SOPs.
• Plan and stage studies including sample handling.
• Compile data and issue periodic stability trending reports.
• Coordinate with internal teams and CROs/CDMOs.

Skills

Detail-oriented

Strong organization skills

Excellent communication skills

Data integrity principles

Knowledge of ICH Q1A–Q1F

Education

BS/BA in Chemistry, Biochemistry, or related field

Tools

LIMS/ELN

Excel/JMP

Empower

Job description

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 <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.

Seniority level

Associate

Employment type

Contract

Job function

Product Management