Job Description
Job Title: QC Environmental Monitoring Technician
Location: Durham, NC
Duration: 6 to 12+ Month Contract
Schedule: 12-hour shifts, 2-2-3 schedule (Days or Nights)
Job Summary:
We are seeking a motivated QC Environmental Monitoring Technician to support environmental monitoring (EM) activities within classified manufacturing, filling, and support areas. This role is critical in maintaining a compliant and inspection-ready cleanroom environment through routine and investigative sampling. The technician will also support daily EM laboratory operations and equipment qualification efforts as needed.
Key Responsibilities:
- Perform routine and investigational EM sampling in classified areas, including manufacturing, filling, and support zones, as well as personnel monitoring.
- Support day-to-day operations of the EM lab, including sample handling, equipment upkeep, and coordination with production teams.
- Ensure compliance with cGMP, data integrity standards, and company Standard Operating Procedures (SOPs).
- Participate in process improvement initiatives and performance optimization within the EM function.
- Maintain readiness for internal and regulatory inspections, ensuring cleanroom control strategies are consistently followed.
- Uphold site and corporate Health, Safety, and Environmental (HSE) goals by promoting a safe and compliant working environment.
- Repeatedly gown aseptically and maintain gowning certification in accordance with Grade A/B cleanroom requirements.
Requirements:
- High school diploma or equivalent required; associate degree preferred.
- Strong understanding of cGMP principles.
- Effective verbal and written communication skills.
- Comfortable working in a fast-paced environment with shift work and occasional weekends.
- Ability to lift up to 30 pounds and perform physical tasks such as pushing, pulling, standing, and walking for extended periods.
Preferred Qualifications:
- Prior experience in environmental monitoring or aseptic manufacturing.
- Background in quality control (QC), quality assurance (QA), regulatory, or technical services in a pharmaceutical or biologics setting.
- Familiarity with parenteral manufacturing environments.
- Experience with lab IT systems such as LIMS, LES, or standalone COTS systems.
- Working knowledge of EM-related regulatory standards (e.g., USP, EU Annex 1).
- Strong documentation and computer skills with keen attention to detail.
- Commitment to continuous improvement and operational excellence.
Additional Information:
- This role involves working in areas where allergens may be present.
- Candidates must be able to successfully maintain gowning qualifications and operate within aseptic cleanroom environments.
Job Tags
Contract work, Work alone, Shift work, Night shift,