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QC Microbiology, Specialist (Contract)

Redwood City, CA 94065

Posted: 03/12/2025 Employment Type: Contract Job Category: Quality Job Number: 4331

Job Description

We are currently seeking an energetic and experienced candidate with a background in microbiology and cleanroom environment to join our client's Quality Control Development (QC) team as a QC Microbiology Specialist. The successful candidate will contribute to the advancement of the product pipeline by editing technical documents, qualifying QC microbiology methods, performing in-house sample analysis, and other assigned tasks. The individual will also be expected to independently organize, analyze, and present results and conclusions.

Key Responsibilities:
  • Review and approve technical documents including SOPs, Test methods, protocols, and reports.
  • Perform equipment qualifications to support product, raw materials, environmental and utility sample testing.
  • Perform method qualification of microbiological assays (Endotoxin, Mycoplasma, Sterility, etc).
  • Troubleshoot method and analytical instrument issues.
  • Train personnel on method and equipment.
  • Contribute to continuous improvement opportunities by optimizing EM and Microbiology assay methods.
  • Investigate invalid events, unexpected Out of Trend and Out of Specification test results. Write the investigation report while collaborating effectively with all impacted departments.
  • Write and ensure timely closure of non-conformance, and CAPA implementation.
  • Maintain critical laboratory reagents needed to support method qualification, and routine microbiological assay testing.
  • Perform routine release and stability testing as needed.
  • Perform environmental monitoring (EM) in cleanrooms and controlled areas as needed.
  • Perform growth promotion testing as needed.
  • Manage multiple projects, and work in a fast-spaced environment.
  • Review QC data including Environmental Monitoring data.

Qualifications:
  • BS or MS in biological sciences or a related field is required.
  • 3+ years of relevant experience in Microbiology laboratory and cleanroom manufacturing environment.
  • Experience/familiarity with various microbiology methods, such as endotoxin, mycoplasma, sterility, growth promotion environmental monitoring, is desirable.
  • Experience with data processing software such as Excel, Word, PowerPoint is desirable.
  • Strong understanding and knowledge of regulatory requirements and industry guidance for Microbiological testing and Environmental Monitoring (USP, ISO, EU Annex etc).
  • The ability to operate for lengthy periods of time while gowning in cleanroom environment is expected.
  • Experience in drafting documents such as SOPs or reports is desirable.
  • Ability to work both independently and in a team environment, multitask and meet deadlines in a fast-paced environment.
  • High initiative, organized, and conscientious record keeping skills, strong attention to detail.
  • Excellent verbal and written communication skills.
  • Ability to utilize troubleshooting and problem-solving skills.
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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!