Job Description
Nature and Scope
The QC Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs) and all other company policies. The Supervisor will liaise with manufacturing leadership to ensure the necessary support required by those areas is provided. The Supervisor will oversee the Environmental Monitoring (EM) program and will provide training, guidance, and support to EM Technicians. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians 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.
Ensure all work is performed and documented in accordance with existing company policies, SOPs, cGMPs, as well as health and safety requirements.
Under the direction of Environmental Monitoring leadership, supervise the Environmental Monitoring program and EM team.
Responsible for completing and maintaining gown qualification and gown training other staff members, where applicable.
Provide technical and administrative support for all activities related to environmental monitoring, and documentation.
Coordinates work projects with the Microbiology Management to appropriately schedule EM workload to meet department/site requirements.
Schedule employees with respect to workload to improve efficiency.
As required, assist EM technicians in sampling and other environmental monitoring responsibilities.
Reviews SOPs 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 a timely manner and present report to Microbiology Management.
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 that the EM areas and EM laboratory is clean and sanitized.
Assist leadership with timely completion of quarterly and other periodic projects and reports.
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.
Bachelor's Degree in Microbiology, Biology, Environmental Sciences or related scientific field, required.
Minimum of 8 years of experience in a pharmaceutical aseptic processing environment required; or MS Degree in Microbiology or related science with three (5) years pharmaceutical aseptic processing environment required.
1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group.
Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program, required.
Experience with instruments such as LIMS, Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required.
Experience with systems such as Trackwise for Deviations, CAPAs and Veeva CR process, required.
Experience in EMPQ, Water PQ, Environmental monitoring, SKAN isolators, Bosch Isolators/Lyo systems, RABs (or equivalent) and standard clean rooms.
Strong experience of aseptic technique and aseptic behavior.
Demonstrate responsibility and accountability working within a multi-disciplinary team environment.
Excellent computer skills and proficiency in Microsoft Office applications such as Word, Excel, and Outlook.
Excellent written and verbal communications skills.
Must be adaptable and maintain flexibility in an ever changing, fast-paced environment.
Flexibility to work multiple shifts and off hours during shutdown plus some overtime. This position is part of a multi-shift operation and may require assignment to a regular off shift and/or weekends schedule
Physical Environment and Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 25 pounds.
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 .
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
