RESPONSIBILITIES
- 50% Sample management (receipt, test scheduling, data review maintenance and reporting)
- 30% QC Personnel Management (time off scheduling, personnel reviews, personnel issues)
- 10% Training Program Management
- 10% Document Control Management (SOPs, Reports, Out of Investigation Reports etc.)
REQUIREMENTS
- Five years working in a GMP quality control laboratory with three years of management / leadership roles
- Experience conducting laboratory/deviation investigations and establishment of appropriate CAPAs (if required)
- Proficient knowledge of GMP regulations including USP and EP testing requirements
- Experience conducting time critical testing of in-process and finished product to meet clinical trial needs.
- Familiarity with flow cytometry, ELISA, endotoxin, PCR
- Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
- Conduct laboratory and deviation investigations and CAPAs as needed
- Knowledge in personnel reviews/ assessments (preferred)
- Technical writing skills for drafting equipment and laboratory standard operating procedures
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