Supervisor, Biological / Environmental Quality (Microbiology Lab)

Position Summary:

The Biological / Environmental Quality (BQ/EQ) Supervisor ensures routine and non-routine testing is performed in support of all aspects of the manufacturing operations including timely release of test results in support of in-process and finished product. This includes, but is not limited to, biological in-process and finished product testing (i.e. bacterial endotoxin, sub-visible particulate, Heparin potency, particulate matter identification) and environmental monitoring of the manufacturing environment and utility systems, bioburden monitoring of incoming raw materials, and in-process product solutions. The BQ/EQ Supervisor may be responsible for investigating product quality and environmental monitoring excursions, as well as laboratory deviations, to determine root cause, provide corrective and preventive actions, and ensure proper actions are implemented.

 

Essential Duties & Responsibilities:

• Supervise and train departmental personnel, both exempt and non-exempt, to assure that testing is performed properly, and products meet industry standards. Ensure the use of validated test methods.
• Ensure procedures are in place for sampling, testing, and documenting the release of materials, intermediates, bulk and finished products, and environmental monitoring data.
• Ensure adequate facilities, instruments, trained personnel and adequate inventory of testing materials for testing of starting materials, bulk intermediate product, and finished products.
• Maintain current understanding of all laboratory and test procedures, and ensure all pertinent specifications and SOPs are audited as needed to ensure continued compliance.
• Ensure deviations are fully investigated and documented and inform appropriate parties when standards/specifications are not met. Advise the Biological Quality (BQ) Manager when testing problems and/or failures occur and provide an analysis of the data with corrective action suggestions.
• Establish work schedules and maintain adequate inventory to sustain the daily activities of the lab area and ensure timely release of products.
• Assist the BQ manager in developing/maintaining a budget for the area, planning the effective use of labor and materials, ensuring quality standards are met, and leading teams on special projects.
• Develop technically sound departmental programs, reviewing and modifying as necessary to meet changing demands and requirements. Provide technical knowledge and leadership in resolution of plant problems, methods development and project work.
• Responsible for certification and recertification of technicians through on the job training, instruction and examinations with continuous performance management post certification utilizing metrics and KPIs. Responsible for certification and recertification of laboratory equipment and test methodology.
• Responsible for departmental activities involved in certification/validation testing and report test results.
• Draft and execution of departmental programs such as Test Method Validation Master Plan, APQR, Management Review, Quarterly Environmental Monitoring Reporting 
• Perform other related duties as assigned or required. This includes, but is not limited to, covering or taking ownership of other BQ/EQ supervisor assigned tasks/responsibilities when that supervisor is out-of-office or as assigned/delegated by BQ management to ensure continuation of business operation. As such, cross training in non-primary core functions is expected (e.g., EQ supervisors will cross train in BET and Particulate Testing for finished product batch release).
• Responsible for providing support as needed during non-business hours (i.e. nights and weekends) including, but not limited to, adverse events (e.g., investigational testing), validation activities (e.g., cleaning validation sampling/testing), compliance related projects and/or activities (e.g., reconciliation of controlled documents) and routine laboratory functions (e.g., support of direct reports who work nights and weekends). 

 

Knowledge, Skills & Qualifications:

• Must have a thorough working knowledge of GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practices) is required including experience with regulatory agencies including the FDA.
• Must be able to independently recognize, investigate and analyze problems concerning specialized and highly technical areas and be capable of making an evaluation as to the relative impact of the problem on the overall quality of the plant and its products. 
• Must demonstrate the ability to accurately assess the potential impact of a problem on final product quality. 
• Must be able to develop a corrective action plan and present a proposed course of action with appropriate suppor