Codon Partners
GMP QC Lab Operations Manager (Contract)
Codon Partners, San Francisco, California, United States, 94199
GMP QC Lab Operations Manager (Contract)
I am looking to speak with QC Consultants for a short term onsite project in the Bay Area, looking for 40 hours a week of support over 3-4 Months assisting with:
Responsibilities
Support method transfer from Analytical Development to QC
Lead Method Qualification activities, including protocol authorship, study execution, data review, and final report approval
Author QC test methods and support routine GMP testing
Review analytical data (including contract labs), issue CoA/CoC, and prepare QC documentation to support batch release
Act as a key QC lead in cross‑functional discussions with AD, Manufacturing, and QA
Support the establishment of QC GMP operations, including:
Drafting and implementing QC SOPs and systems
Defining the sample management process
Leading and supporting risk assessments
Identifying OJT and training requirements for QC Analysts
Ideal Experience Our client is specifically seeking experience qualifying early‑phase analytical methods to support mRNA product release
Notes
40 Hours Per Week over 3 to 4 Months
Start in January
Key Details
Seniority level: Not Applicable
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Location: Fremont, CA | Salary: $130,000.00-$140,000.00 (2 weeks ago)
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Responsibilities
Support method transfer from Analytical Development to QC
Lead Method Qualification activities, including protocol authorship, study execution, data review, and final report approval
Author QC test methods and support routine GMP testing
Review analytical data (including contract labs), issue CoA/CoC, and prepare QC documentation to support batch release
Act as a key QC lead in cross‑functional discussions with AD, Manufacturing, and QA
Support the establishment of QC GMP operations, including:
Drafting and implementing QC SOPs and systems
Defining the sample management process
Leading and supporting risk assessments
Identifying OJT and training requirements for QC Analysts
Ideal Experience Our client is specifically seeking experience qualifying early‑phase analytical methods to support mRNA product release
Notes
40 Hours Per Week over 3 to 4 Months
Start in January
Key Details
Seniority level: Not Applicable
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Location: Fremont, CA | Salary: $130,000.00-$140,000.00 (2 weeks ago)
#J-18808-Ljbffr