Manager of Sterility Assurance

Biovire • Brighton, MI

22h

About The Position

General Description The Manager of Sterility Assurance is a member of the Quality Assurance department responsible for overseeing and assisting in all aspects of Sterility Assurance oversight. The Manager of Sterility Assurance role will function in three capacities: 1) Oversight, maintenance, and SME of the Environmental Monitoring and Aseptic Process Simulation Programs. 2) Manage Environmental Monitoring Technician/s. 3) Support for other aspects of Environmental Control within the Biovire Facility. DUTIES AND RESPONSIBILITIES The Manager of Sterility Assurance will lead a team and sterility assurance programs, including environmental monitoring, aseptic process simulation activities, facility cleaning / disinfection program, gowning practices, personnel / material flows, aseptic techniques/training, cleanroom behaviors, and cleanroom classification, as well as the Contamination Control Strategy.

Requirements

• BS in a scientific discipline required
• 5+ years' experience in the biotech / pharmaceutical industry, with 2+ years in Sterility Assurance / Environmental Monitoring.
• Demonstrated knowledge and understanding of CGMP with a focus on ISO14644 and USP 1116.
• Advanced knowledge of microbiology and aseptic principles.
• Excellent written and verbal communication skills and cross-functional partnership.
• Strong work ethic and ability to accomplish tasks without supervision
• Exhibits leadership, both by work and example
• Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment
• Excellent interpersonal skills with the ability to communicate effectively
• Basic computer skills (proficient in Microsoft Office applications)
• Excellent communication skills, both written and verbal
• Possess honesty and integrity with a commitment to the highest legal and ethical standards
• Treats every person with courtesy and respect
• Knowledge of CGMP, regulatory principles, and ISO standards
• Commitment to quality in the manufacturing process
• Ability to independently analyze and resolve complex issues
• Strong sense of initiative, accountability, and responsibility

Responsibilities

• Build and maintain effective and compliant sterility assurance program that adheres to federal, regulatory, industry, and customer standards.
• Serve as the SME (Subject Matter Expert) for all sterility assurance related controls / initiatives at the site. This would include (but not limited to) facility cleaning / disinfection, gowning practices, personnel / material flows, aseptic techniques / training, cleanroom behaviors, cleanroom classification, etc.
• Directly oversee the technician/s collecting facility environmental monitoring surface and air samples, maintaining adherence to schedule requirements.
• Generate Environmental Monitoring and Aseptic Process Simulation protocols in accordance with established procedures as necessary to facilitate new product introductions.
• Monitor Aseptic Process Simulation program to ensure qualification/re-qualification of both process and personnel. Draft reports as necessary to summarize results.
• Enter environmental monitoring results into internal database and create reports as required.
• Investigate, review, approve deviations against the Environmental Monitoring or Aseptic Process Simulation Programs. Aid in determining impact for all other investigations which may affect sterility assurance.
• Process owner for the Aseptic Process Simulation and Environmental Monitoring Master Plans and all associated SOPs.
• Other duties as defined by Biovire.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees