Redbock - an NES Fircroft company
Quality Control Technician
Redbock - an NES Fircroft company, Salt Lake City, Utah, United States, 84193
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.
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.
Seniority level Associate
Employment type Contract
Job function Product Management
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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.
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.
Seniority level Associate
Employment type Contract
Job function Product Management
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