QC Associate I

Responsibilities:

• Excellent employment opportunity for a QC Associate I in the Fremont, CA area.
• Day to day duties will include but not limited to: Collect routine Environmental Monitoring and Utility samples from Manufacturing plant
• Perform LAL and Bioburden testing of environmental monitoring samples, in-process samples, raw materials, equipment rinses and bulk drug substance using Chromogenic, and Turbidimetric method and Membrane Filtration, and Pour plate method, respectively.
• Perform growth promotion testing of microbiological media.
• Assist in writing periodic trend reports and analysis of microbiological data.
• Perform laboratory investigations of microbiology excursions.
• Enter data in LIMS or other databases in a timely manner.
• Other miscellaneous Laboratory maintenance activities.
• Should be able to lift, carry, push or pull up to 50 pounds occasionally.
• Assist in revising and creating Standard Operating Procedures.
• Perform document review as required.

Experience:

• BS Degree in Science (Preferably in Microbiology) Years of Experience: 1+ years of experience in cGMP regulated industry or equivalent college experience preferred.
• Demonstrates proficient computer skills (i.e., documentation systems, databases and spreadsheets) knowledge of Microsoft applications, must be able to use computers to perform data-entry functions etc.
• Demonstrates excellent interpersonal and communication skills (both written and oral)
• Demonstrates ability to work under minimal direction and as part of a team
• Demonstrates strong attention to detail
• Demonstrates good facilitation, organizational and problem-solving skills
• Must have working knowledge of relevant Standard Operating Procedures, U.S. and E.U. Good Manufacturing Procedures and other regulatory requirements
• Shift: 2^nd, Wednesday to Saturday, 11:00am 10:00pm
• Must be able to work flexible hours including weekends, if needed.