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About the Role
The Environmental Monitoring Team is responsible for ensuring the environmental control of the aseptic manufacturing facility by performing environmental monitoring activities. This includes sample collection of water, air, compressed gas, surfaces, and personnel within classified areas.
Responsibilities
- Ensure all work is performed and documented in accordance with company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
- Manage daily workload to meet requirements and perform sampling as per the schedule.
- Complete and maintain gowning qualifications for support areas and the Aseptic Processing Area.
- Perform environmental monitoring activities including sampling of air (Viable and Non-viable), compressed air and nitrogen, surface, and personnel inside classified manufacturing areas.
- Conduct water sampling throughout the facility.
- Complete incubation, transfer, and final reading of samples.
- Record results and report deviations as per specifications.
- Capture sampling life cycles in LIMS software and assist with data entry for retrieval and trending from Labware LIMS.
- Maintain accurate records of work performed in Labware LIMS and Laboratory documentation systems.
- Maintain compliance with all required SOPs and policies.
- Communicate any discrepancies or deviations to supervision/management upon discovery.
- Author or assist with data collection for assigned investigation reports related to EM/PM events.
- Perform clean room behavior and area assessments as per procedures.
- Review environmental and personnel monitoring sample results in Labware LIMS.
- Input data/results into database and conduct trend analysis.
- Perform any other tasks/duties as assigned by management.
Requirements
- Must be able to maintain APA gown qualification for EM support.
- Ability to perform basic mathematical calculations.
- Ability to work independently and as a team with minimal supervision.
- Organization and attention to detail.
- Excellent communication skills (Oral and Written).
- Working knowledge of MS-Office software and PC Skills Required.
- Good work ethic and highly motivated.
- Good time-management skills.
- Ability to work in a fast-paced environment.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Ability to work overtime, weekend and holidays as needed.
- Physically able to wear and aseptically don cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
- Maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
- Able to occasionally lift and/or move up to 25 pounds.
- Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.
Skills
- Microbiology
- Aseptic technique
- MS-Office software
- PC Skills
Location
- Onsite
Work Type
- Full-time
Experience Level
- 1 year experience in laboratory setting or manufacturing with focus on microbiology preferred.
Education Level
- High School Diploma or GED equivalent required.
- Associate degree in microbiology, biology or related scientific field preferred.
Salary/Compensations
- $23.61 - $25.00 per hour
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
- Wide range of other benefits
About the Company
- American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees.
Equal Opportunity
- 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