Quality Control Associate II

3 days ago


Fremont, California, United States PSG Global Solutions Careers Full time
Job Title: Quality Control Associate II

At PSG Global Solutions Careers, we are seeking a highly skilled Quality Control Associate II to join our team. As a key member of our laboratory, you will be responsible for ensuring the quality and safety of our products.

Key Responsibilities:
  • LAL (Endotoxin) and Bioburden testing of in-process samples, raw materials, equipment rinses, WFI, and bulk drug substance.
  • Bioburden testing using Membrane Filtration method and Pour plate method.
  • Biological indicator (BI) testing for autoclave validation.
  • Gram staining, and microbial identification of Environmental Monitoring samples, and In Process Testing samples.
  • Growth promotion testing and release of microbiological media.
  • Assist in the preparation of periodic trend reports and analysis of microbiological data.
  • Assist in laboratory investigations of microbiology excursions.
  • Enter data in QC LIMS or other databases in a timely manner.
  • Perform other miscellaneous Lab maintenance activities.
Requirements:
  • BS Degree in Science (Preferably in Microbiology)
  • 2 or more years of experience in cGMP regulated industry (Preferably in QC Microbiology lab)
  • 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 experience with Pipetting
  • 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
About Our Client:

Our client is an award-winning clinical development company with 20+ years of experience in clinical research and strategic resourcing. They are committed to improving lives globally and are seeking a highly skilled Quality Control Associate II to join their team.

As a Quality Control Associate II, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality products. You will be responsible for ensuring the quality and safety of our products, and will have the opportunity to develop your skills and expertise in a dynamic and fast-paced environment.

If you are a motivated and detail-oriented individual with a passion for quality and safety, we encourage you to apply for this exciting opportunity.



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