Redbock - an NES Fircroft company
QC Stability Coordinator
Redbock - an NES Fircroft company, Salt Lake City, Utah, United States, 84193
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.
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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$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.
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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