Manager of Sterility Assurance

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.

Essential Duties and Responsibilities:

1. Build and maintain effective and compliant sterility assurance program that adheres to federal, regulatory, industry, and customer standards.

2. 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.

3. Directly oversee the technician/s collecting facility environmental monitoring surface and air samples, maintaining adherence to schedule requirements.

4. Generate Environmental Monitoring and Aseptic Process Simulation protocols in accordance with established procedures as necessary to facilitate new product introductions.

5. Monitor Aseptic Process Simulation program to ensure qualification/re-qualification of both process and personnel. Draft reports as necessary to summarize results.

6. Enter environmental monitoring results into internal database and create reports as required.

7. 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.

8. Process owner for the Aseptic Process Simulation and Environmental Monitoring Master Plans and all associated SOPs.

9. Other duties as defined by Biovire.

Behavioral Expectations:

1. Strong work ethic and ability to accomplish tasks without supervision,

2. Exhibits leadership, both by work and example,

3. Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment,

4. Excellent interpersonal skills with the ability to communicate effectively,

5. Basic computer skills (proficient in Microsoft Office applications),

6. Excellent communication skills, both written and verbal,

7. Possess honesty and integrity with a commitment to the highest legal and ethical standards,

8. Treats every person with courtesy and respect,

9. Knowledge of CGMP, regulatory principles, and ISO standards,

10. Commitment to quality in the manufacturing process,

11. Ability to independently analyze and resolve complex issues,

12. Strong sense of initiative, accountability, and responsibility

WORK EXPERIENCE AND education 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.