Environmental Monitoring Associate III
As a key member of the Quality Assurance department, the Senior QA EM Associate will support the Environmental Monitoring Program in a GMP Quality organization. The candidate will ensure that all aspects of Environmental Monitoring for water, compressed gases, personnel and facility will be performed.
Duties and Responsibilities
- Perform Environmental monitoring in an aseptic environment (batch, routine, gowning monitoring and utilities testing).
- Assist with the set up on EM laboratory and manage the EM lab daily operations
- Incubate and Enumerate organisms on cultured media.
- Provide EM support including review, tracking of EM of Microbiology results in support of product release.
- Responsible for the accurate recording, review and storage of laboratory data
- Ensure timely completion and subsequent data review of routine microbiological data
- Facilitate and assist with facility qualification
- Ensure proper equipment function, calibration, maintenance and trouble shooting of laboratory equipment
- Initiate, investigate and complete investigations (Excursions, CAPA, DR) to aid in the determination of root causes
- Support regulatory inspections
- Train other EM Associates
- May perform other related duties as required and/or assigned.
- A minimum Bachelor’s degree in a scientific discipline is required, Microbiology degree preferred.
- A minimum experience of 10 years in the drug/device pharmaceutical and biopharmaceutical
- A minimum of 7 years in Microbiology and Environmental Monitoring.
- Strong verbal, written communication skills and computer skills are required.
- Must be goal-oriented, quality-conscientious, and customer-focused.
- Proficiency in Excel is highly desirable.