Environmental Monitoring Specialist

2 days ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Summary

Lynkx Staffing LLC is seeking a highly skilled Quality Control Microbiologist to join our team. As a Quality Control Microbiologist, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Perform environmental monitoring activities, including non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.
  • Ensure equipment is in proper working condition, properly maintained, and calibrated.
  • Coordinate data for batch release and participate in project/client meetings.
  • Author and revise environmental monitoring procedures, Standard Operating Procedures, and Work Instructions.
  • Review investigations and document non-confirming events and environmental excursions.
  • Apply expertise of compliance requirements to maintain an inspection-ready state.
  • Participate and act as a subject matter expert during audits/inspections.
  • Develop and train QC Microbiology Analysts on relevant business processes.
Requirements
  • Bachelor's degree in a science or relevant field required or equivalent experience; minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
  • GxP/GDP trained.
  • Proficient with computer software such as Microsoft Office, MODA/LIMS.
  • Familiarity with ISO and EU standards.
  • Strong written and oral communication skills.
  • Technical training ability.
  • Ability to work in a team-oriented environment and with clients.
  • Ability to work during the weekend, holidays, and as required by the company.
  • Ability to handle the standard/moderate noise of the manufacturing facility.
Working Environment
  • Occasional exposure to infectious diseases transmittable through human blood, tissues, or bodily fluids.
  • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
  • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.


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