Job Title: QC Associate

This position require flexibility in the working hours in the weekends if needed.

Job Responsibilities:

• 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 Lab 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.

Other:

• 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
•    • Must be able to work flexible hours including weekends, if needed

#P2

Minimum Education / Experience:

• BS Degree in Science (Preferably in Microbiology)

Years of Experience: 

• 1+ years of experience in cGMP regulated industry or equivalent college experience preferred.

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