Nature and Scope

The Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians and EM Microbiologists in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs, safety and all other company policies. The Supervisor will liaise with Production/Compounding Supervisor and Production/Filling Supervisor to ensure the necessary support required by those areas is provided. The Supervisor will oversee the environmental monitoring program and will provide training, guidance, and support to EM Technicians and EM Microbiologists. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians/Microbiologists and provide input and assistance to other departments as needed.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Under the direction of the QC Sr. Manager, supervise the environmental monitoring program.
• Review and sign as responsible individual all test data generated by the Environmental Monitoring Department or assign this task to qualified responsible individuals.
• Oversee/perform investigations as required of SOP and CGMP deviations as they apply to the EM Laboratory.
• Responsible for completing and maintaining gown qualification and gown training other staff members
• Provide technical and administrative support for all activities related to environmental monitoring, and documentation.
• Reviews SOP's as necessary, recommend changes, update and initiate change controls as needed.
• Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion.
• Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner
• Perform and maintain environmental monitoring tracking and trending of data in timely manner and present report to QC Sr. Manager.
• Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary.
• Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring.
• Ensure validation studies are conducted as required.
• Conduct special studies as required.
• Ensure that the EM laboratory is clean and sanitized.
• Assist the laboratory manager where required.
• Perform other duties as required.
• Temporarily perform Manager's duties to cover short absence.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• BS Degree in Microbiology or related science with a minimum of eight (8) years pharmaceutical laboratory experience, required; or MS Degree in Microbiology or related science with five (5) years pharmaceutical laboratory experience, preferred.
• Minimum of two years supervisory/management experience.
• Proficient in MS Word, Excel and Outlook.
• Strong oral and written communication skills.
• Strong time management and organizational skills, able to delegate tasks as needed.

Physical Environment and Requirements

• Specific vision requirements include 20/40 (can be corrected with eyeglasses or contacts) and color vision.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, masks, and protective gloves. PPE are essential for the health and safety of employees.
• Employee must be able to stand for extended periods of time.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .