QC Environmental Monitoring Technician I (5pm-1:30am)

Nature and Scope
The Environmental Monitoring Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility.

Responsibilities

• Perform environmental monitoring activities including sample collection of water, air (viable and non-viable), compressed gas, surfaces, and personnel within the classified areas of the manufacturing facility.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Manage assigned daily workload to meet requirements and perform sampling as per the schedule.
• Complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms.
• Perform environmental monitoring activities including sampling of air (viable and non-viable), compressed air and nitrogen, surface, and personnel inside the classified manufacturing areas.
• Conduct water sampling throughout the facility.
• Complete incubation, transfer, and final reading of samples if needed.
• Record results and report deviations as per specifications.
• Capture sampling life cycles in the 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 according to Good Documentation Practices, Standard Operating Procedures (SOPs), and policies.
• Maintain compliance with all required SOPs and policies.
• Communicate any discrepancies or deviations to supervision/management upon discovery.
• Author or help with data collection for assigned investigation reports related to EM/PM events.
• Perform clean room behavior and area assessments as per procedures if needed.
• Review environmental and personnel monitoring sample results in Labware LIMS if needed.
• Input data/results into the database and conduct trend analysis.
• Perform any other tasks/duties as assigned by management.

Requirements

• High School Diploma or GED equivalent required; Associate degree in microbiology, biology, or related scientific field preferred.
• One year of experience in academic or industry work in a laboratory setting or manufacturing with a focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• 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, weekends, and holidays as needed.

Physical Environment and Requirements

• 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.
• Must 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.
• Must be 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.

Pay

Expected hourly range: $23.61 - $25.00. The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills, and experience.

Benefits

• Healthcare
• Life insurance
• Profit sharing
• Paid time off
• Matching 401k
• Wide range of other benefits