QC Environmental Monitoring Supervisor

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, cGMPs 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. 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.

• Under the direction of the Microbiology Manager, supervise the environmental monitoring program and technicians.
• Responsible for completing and maintaining gown qualification and gown training other staff members (Hilliard).
• Provide technical and administrative support for all activities related to environmental monitoring, and documentation.
• Coordinates work projects with the Microbiology Manager 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 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 Microbiology 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.
• Assist Manager 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.

• High School Diploma or GED equivalent required. Bachelor's Degree in microbiology, biology or Environmental Sciences or related scientific field preferred.
• 2 -3 years experience in a pharmaceutical aseptic processing environment, production QA, aseptic testing, medical device or food industry in area of microbiology or a combination required.
• 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 like Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required.
• Minimum 1-2 years of lead or supervisory experience preferred.
• Must flexible with working hours dependable and able to work overtime as needed, according to the production schedule.
• Demonstrate responsibility and accountability working within in a multi-disciplinary team environment.
• Ability to mentor subordinates.
• Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook.
• Excellent communications skills both verbal and written.
• Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment.
• Sense of ownership and ability to take responsibility
• Ability to work overtime as needed.

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 20/40 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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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