Sterility Assurance Program Manager
The Sterility Assurance Program Manager is responsible for expertise in the area of sterility assurance for all sterilization processes. This position collaborates with R&D, Production, and other areas to define process development and qualification activities for new products as it relates to sterilization of products. In addition, manages all aspects of the sterility assurance program to include, but not limited to; component qualification, environmental controls, change control including facility qualification/ change assessment and product introduction/ change assessment, bioburden program, and all sterilization validation activities and routine release. Oversees the microbiology laboratory and environmental monitoring staff.
Duties and Responsibilities
- Manage quality aspects of routine sterilization and sterilization validation, to include assessment of changes (facility, process, product) that could potentially impact sterility assurance levels.
- Manages environmental control program including monitoring and related failure investigations.
- Manages product / component bioburden program and related investigations in support of sterilization validation.
- Must be able to interact with internal and external customers in a professional manner both orally and in written communications.
- Staff management – direct employees in a manner to ensure responsibilities are executed as required as dictated by the needs of the organization.
- Regulatory compliance – ensures all activities are executed in full compliance with the most current and relevant standards (e.g. ISO 13485, ISO 14644, ISO 11137, FDA 21 CFR Part 820).
- Staff selection, assessment, and development – ensures employees are proficient in areas of responsibility.
- Responsible for housekeeping and safety awareness for areas of responsibility.
- Participate in audits of sterilization and laboratory services.
- Proficient use in Microsoft Office Suite
- Other duties as assigned.
- Knowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable to manufacturing environments that produce components or devices for the medical industry.
- Expertise in irradiation sterilization and associated international standard(s), ISO 11137.
- Knowledgeable of EO sterilization validation and associated international standard(s), ISO 11135.
- Knowledgeable in facility qualification as it related to controlled environments and cleanrooms, ISO 14644
- Knowledgeable in standard microbiological testing relevant to medical device and/ or pharmaceutical industries, such as bioburden and sterility.
- Strong problem-solving skills as it related to microbiological contamination control (environment, bioburden, sterility). Ability to drive investigation to closure.
- Strong attention to detail with good documentation practices.
- Ability to manage competing demands, set priorities to ensure compliance and meet company goals.
- Strong reasoning and judgment skills to ensure timely, sound decisions even under conditions of risk, uncertainty, and incomplete information – ability to determine when to escalate a situation when required.
- Ability to act with professionalism, integrity, and superior confidentiality.
- Strong communication/interpersonal skills as well as time management skills.
- Ability to include appropriate people in decision-making process.
- Ability to work independently as well as with a team.
- Strong team building skills; promoting a positive team spirit, exhibiting objectivity and openness to views and opinions of coworkers.
- Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills.
Education and Experience
- Bachelor’s degree in biological science discipline plus five (5) years’ experience in management of controlled environments and terminal sterilization.