Title : QC Environmental Monitoring Technician
Duration : 6 12-month contract
Location : Durham, NC
- First and second shift work may be required.
- 12 hour shifts on 2-2-3 schedule
- Minimal travel required.
- Some allergens are present in the parenteral plant.
Summary :
The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas.
Support daily EM laboratory operations.
Responsibilities :
- Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.
- Support daily EM laboratory operations and process / equipment qualification activities, as necessary.
- Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
- Ensures that data-integrity is maintained
- Participate in process streamlining and continuous performance improvement.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- EM Technician requires gowning certification, and repeatedly aseptically gown daily.
Requirements :
- High School Diploma or equivalent, Associates degree preferred.
- Understanding of cGMP
- Excellent written and oral communication skills and ability to collaborate and interact with a team.
- Work in a dynamic and fast paced environment with potential to work shifts and weekends.
- Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.
- Must be able to stand / walk for extended periods of time.
Preferred Qualifications :
- Environmental Monitoring experience preferred.
- Manufacturing or production experience preferred.
- Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
- Technical writing and written communication skills are a plus.
- Understanding of regulatory standards / requirements for EM.
- Knowledge of / familiarity with Parenteral production environments and operations.
- Strong computer skills, documentation skills, and attention to detail.
- Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
- Ability to focus on continuous improvement.
- Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
- Understanding of compliance requirements and regulatory expectations for lab systems.
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