Redbock - an NES Fircroft company
Quality Control Coordinator
Redbock - an NES Fircroft company, Salt Lake City, Utah, United States, 84193
Base pay range
$30.00/hr - $40.00/hr
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.
This role owns day‑to‑day stability logistics (staging, pulls, shipments, data collection), generates and maintains stability protocols and trending reports, trends data for critical reagents and assay controls, and compiles system suitability data to set and track assessment due dates. 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.
#J-18808-Ljbffr
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.
This role owns day‑to‑day stability logistics (staging, pulls, shipments, data collection), generates and maintains stability protocols and trending reports, trends data for critical reagents and assay controls, and compiles system suitability data to set and track assessment due dates. 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.
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