Overview
Quality Control – Environmental Monitoring Technician Jobs in Bethlehem, PA at Particle Sciences Inc, an Agno Pharma Company
Position Summary
The QC – Environmental Monitoring Technician performs routine environmental and utility monitoring activities supporting GMP manufacturing operations. The position is responsible for monitoring classified areas, personnel, WFI, compressed gases, and other applicable systems while ensuring accurate documentation, proper sample handling, and timely escalation of potential quality concerns.
Essential Responsibilities
- Perform routine Environmental Monitoring (EM) of classified cleanrooms and associated controlled areas in accordance with approved procedures, sampling plans, and cGMP requirements.
- ·Perform viable, non-viable, surface, and personnel monitoring, including active air sampling, settle plates, surface sampling, particle monitoring, and glove/gown sampling, as applicable.
- ·Perform EM in support of routine manufacturing, aseptic processing, media fills/aseptic process simulations, facility qualification/requalification, and other validation activities.
- Perform routine sampling and monitoring of Water for Injection (WFI), compressed gas, and other applicable facility utility systems, including microbiological and particulate monitoring as required.
- Properly collect, identify, handle, transport, incubate, and/or submit environmental and utility samples for testing in accordance with established procedures and sample hold times.
- Operate EM and sampling equipment, including active air samplers and non-viable particle counters, and verify equipment is within required calibration or qualification status prior to use.
- Accurately document EM and utility sampling activities in controlled records and applicable electronic systems in accordance with Good Documentation Practices (GDocP).
- Review monitoring documentation for completeness and accuracy and promptly escalate adverse conditions, excursions, discrepancies, or other potential quality events.
- Support investigations and trending of EM and utility monitoring results, including compilation of data and provision of sampling records and observations.
- Support deviations, CAPAs, change controls, risk assessments, and continuous improvement activities associated with environmental and utility monitoring.
- Support development and revision of EM procedures, forms, sampling plans, and related controlled documentation.
- Maintain appropriate aseptic behaviors, gowning practices, and required personnel qualifications when working within classified manufacturing environments.
- Maintain EM equipment, supplies, and sampling materials in a state of readiness and identify equipment requiring calibration, maintenance, or service.
- Provide routine technical support to Manufacturing and other functions regarding environmental monitoring, utility sampling, and contamination control requirements.
- Support internal audits, client audits, and regulatory inspections and collaborate with Quality Control, Manufacturing, Quality Assurance, Validation, Engineering, and other functions in support of the site’s Environmental and Utility Monitoring programs.
Qualifications
- Bachelor’s degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline preferred; an equivalent combination of education and relevant experience may be considered.
- Two (2) or more years of experience in Environmental Monitoring, microbiology, Quality Control, or pharmaceutical manufacturing within a GMP-regulated environment preferred.
- Experience performing viable and non-viable environmental monitoring, including air, surface, and personnel monitoring, preferred.
- Experience supporting aseptic or sterile pharmaceutical manufacturing and working within classified cleanroom environments strongly preferred.
- Experience with WFI, compressed gas, or other GMP utility sampling and monitoring preferred.
- Working knowledge of cGMP, Good Documentation Practices (GDocP), aseptic technique, contamination control, and basic microbiological principles.
- Experience operating environmental monitoring equipment such as active air samplers and non-viable particle counters preferred.
- Familiarity with environmental monitoring investigations, trending, deviations, CAPAs, change controls, and qualification activities is desirable.
- Ability to accurately execute approved procedures and sampling plans and maintain complete and contemporaneous GMP documentation.
- Strong attention to detail with effective organizational, communication, analytical, and problem-solving skills.
- Ability to work independently while effectively collaborating with Quality Control, Manufacturing, Quality Assurance, Validation, and Engineering.
- Must be able to complete and maintain required aseptic gowning qualifications and cleanroom certifications, as applicable to assigned responsibilities.
Agno Pharma is an Equal Opportunity Employer
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
- Bachelor’s (Preferred)
Ability to Commute:
- Bethlehem, PA 18017 (Preferred)
Work Location: In person
Title: Quality Control – Environmental Monitoring Technician
Company: Particle Sciences Inc, an Agno Pharma Company
Location: Bethlehem, PA
Category:
