Quality Control Microbiology
Summary:
Provides leadership to QC Environmental Monitoring Associates to ensure that QC processes are optimized and supervised effectively and efficiently.
Emphasis will be placed on microbiological testing, such as sterility, Gram stain and environmental monitoring.
Key
Responsibilities:
Supervise QC EM Associates and provide clear objectives for daily operations Work in tandem with the QC Analytical Supervisor and serve as their back up Establish and monitor QC programs and procedures to ensure compliance with compendial standards Provide on-the-floor support for QC Associates during daily operations, serving as an active presence in the laboratory Work closely with the individual Operations Departments (Manufacturing, Quality Assurance and Facilities) to ensure that Company objectives are met on schedule Write and revise QC Standard Operating Procedures and Analytical Test Methods as necessary to maintain compliance Training and development of employees Ensure adherence to SOPs Ensure full compliance with applicable health and safety regulations (OSHA) is achieved and maintained Development of goals for direct reports Conduct yearly performance reviews of employees, monitoring progress toward objectives Assist the Manager of QC in daily operations, as needed Additional Responsibilities may Include:
Review of Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product Timely response to Out Of Specification (OOS) results, including notification to area management Maintaining the viable and non-viable EM Program, ensuring monthly trend analysis and yearly evaluation of alert and action levels, as compared to historical data and compendia standards Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented Ensuring adequate and complete Installation/Operation/Performance Qualification for laboratory equipment Ensuring all method validation is current Maintaining traceability of sample management within the laboratory and establishing testing priority of samples Supervise the Quality Control Associates in the performance of the following:
Execution of testing for raw materials Execution of viable and non-viable environmental monitoring Housekeeping of the laboratories Requirements:
Minimum Bachelor of Science degree in a scientific discipline Minimum 3 years QC experience in a similar role in the biologics or pharmaceutical industry Excellent knowledge of CGMPs guidelines, 21 CFR Part 11 and other regulatory standards Excellent verbal and written skills Ability to execute multiple tasks Good interpersonal communication skills Experience in aseptic processing and mammalian cell culture production considered a plus Recommended Skills Asepsis Biopharmaceuticals Communication Housekeeping Interpersonal Communications Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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