Job Number: 9147
Primary responsibilities will be to support, plan, manage, and execute the daily, short term and long term activities, and goals associated with microbiology lab, environmental monitoring, sterilization, pyrogen and bioburden testing programs within the Quality Operations team to support the manufacturing of biologic products.
Assure that lab activities are in compliance with the respective areas that are applicable from FDA GMP/GLP, and other national and international standards as necessary.
Manage tasks and manage performance of assigned group of staff in the microbiology department, to accomplish company and departmental objectives.
Maintain all activities associated with, microbiology lab, environmental monitoring, sterilization, and related testing programs to support product release testing.
Support internal and external audits as the microbiology, sterilization, endotoxin bioburden, and environmental monitoring and inspection subject matter expert.
- Support vendor audits for initial qualification and compliance
Provide data review, process trending, and procedural updates and provide technical support for validation protocol writing
- Own and monitor QC Microbiology trending programs.
- Assign, monitor and review progress and accuracy of work of employees.
Maintain Quality Systems as related to the QC Microbiology laboratory function, such as Deviations, CAPAs, and Change Control tasks
- Draft deviation assessments of events for OOS results related to Environmental Monitoring and Microbiological testing
- Provide input on impact assessment and root cause for investigations
Oversee qualification/verification of analytical test methods and instrumentation including supporting documentation, procedures, protocols and reports.
- Perform routine maintenance of laboratory equipment.
- Train and mentor laboratory personnel in basic and complex laboratory techniques.
Work on assigned projects independently with limited supervision.
Follow technology changes, recommends new technologies, purchase and implement if appropriate. Schedules projects to ensure that deadlines are met.
Follow GMPs and comply with all safety regulations.
Work with Quality and the Operations Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, and celebration of good work, involvement and development of all people within the team.
Instill a sense of urgency to ensure goals are met in a timely manner while meeting regulatory and quality standards and customer requirements.
Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
Communicate effectively to all levels of an organization.
Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
Perform other duties assigned by supervisor.
A minimum of a Bachelor s degree with a focus on science or engineering is required
Master s Degree in business or related field of study is preferred
A minimum of 8 years of related experience in a highly regulated, GMP environment is required
Prior Lead/Supervisory/Management experience in a laboratory environment is required
Experience interacting with various regulatory bodies including the FDA is required
Experience with root cause analysis and driving laboratory investigations is required
Knowledge of Process Excellence principles desirable
Experience providing final approval on various technical documents including process validation reports, cleaning validation reports, lab protocols, and SOPs is preferred
Experience managing laboratory operations including scheduling of testing personnel and budget oversight is preferred
Prior experience managing method transfers is preferred