Job Description

6 month contract with probability of extensions

onsite in Durham, NC

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.

Additional Information:

• Minimal travel required.
• Some allergens are present in the parenteral plant.
• 12 hour shifts on 2-2-3 schedule, days or nights

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