What are the responsibilities and job description for the Microbiology Specialist position at Unicon Pharma Inc?
About the Engagement:
The client is undertaking a large-scale assessment and remediation effort involving approximately 200 analytical chemistry and microbiology methods. The project will focus on evaluating existing method transfer packages, identifying gaps related to missing raw data or outdated documentation, and determining which methods require re-execution.
Responsibilities:
- Method transfer activities, protocol writing and execution
- Risk assessments and investigations
- Analyst training and knowledge transfer
- Documentation remediation and final report generation
- GMP documentation within a regulated environment
- Cross-functional collaboration with QC, QA, and lab operations teams
Ideal Background:
QC, Analytical Chemistry, Microbiology, Analytical Development, Method Validation, or Technical Transfer. GMP laboratory experience and cross-functional collaboration with QA/QC teams highly preferred.