Quality Control Microbiology Supervisor
Summary:
In this Hands-On position, the incumbent is responsible for overall operations of the Microbiology laboratory in a cGMP environment . Manages raw material and component testing, assay development and validation, contract testing, environmental monitoring and in-process and finished product microbiological testing.
Essential Duties:
- Identify, develop and validate assays for raw material, in-process and finished product testing per appropriate GMP, USP and ICH requirements or guidelines.
- Oversight of the environmental monitoring program and related trending.
- Write SOPs, programs and specifications necessary for laboratory operations.
- Identify, evaluate and purchase microbiological laboratory equipment.
- Participate in the validation of the manufacturing plant systems and processes.
- Manage the laboratory in accordance with GMPs, OSHA, DEA and FDA regulations.
- Develop quality systems for microbiology including specialized training programs.
- Write technical reports and perform data trending analysis.
- Direct, perform and resolve out-of-specification investigations and implement corrective and preventative actions.
- Manage projects related to establishing new capabilities and/or drug development programs.
- Audit external suppliers and contract service providers for GMP compliance as related to microbiological control and testing.
- Participate in DEA licensing and reporting activities.
- Provide quotations and interface with clients and partners as related to microbiological testing.
- Train and supervise 1 or more direct reports.
Minimum Qualifications:
- BS in Microbiology or related field
- 7 years of applicable experience in a pharmaceutical laboratory
- Knowledge and experience in an aseptic processing environment is preferred
- Hands on experience using laboratory instrumentation
- Experience performing microbiological testing and environmental monitoring
- In depth knowledge of cGMP regulatory requirements
- Ability to manage and develop staff
- Excellent technical writing and organizational skills
- Qualified to work with controlled substances
- Good interpersonal skills and the ability to work well in a team environment