General Tasks & Responsibilities:
- Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods.
- Training Coordinator
- Train staff on all techniques and methods used in the laboratory
- Document and sign off training plans
- Exception investigation and management
- Conduct and complete OOS investigations and other exceptions, in coordination with the Department Head.
- Support in the preparation and maintenance of SOPs, procedures and work instructions for the Microbiology laboratory.
- Coordinate the scheduling of samples to assigned Microbiology staff and ensure testing is started and completed in a timely manner.
- Occasional client communication where needed.
- Adhere to appropriate quality measures to meet or exceed current GMP standards, government regulatory, and company requirements relevant to assigned duties.
- Maintaining a neat and accurate record system of work performed on a daily basis and as needed for quality control tests or regulatory purposes.
- Perform sample preparation and analysis. Ensure a high level of accuracy.
- Ensure sample turnaround time goals are met or exceeded.
- Ensure to manage the cleaning and sanitization of the microbiology laboratory.
- Quality control procedures.
- Perform other related duties as assigned.
Technical Skills:
- Good computer skills - proficiency with MS Office;
- Working knowledge of Laboratory Information management Systems (LIMS).