Environmental Monitoring Associate III

Location
Hayward, California
Posted
Oct 17, 2017
Required Education
Bachelors Degree
Position Type
Full time

Your Opportunity:

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.

Qualifications:

  • A minimum Bachelor’s degree in a scientific discipline is required, Microbiology degree preferred.

Experience:

  • 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.