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.

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