Senior QC Microbiologist
 
Kelly® Science & Clinical is seeking a Scientist for a temp-to-hire position at a company in Petaluma, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:  
$55-60/hour

Overview:
The Senior QC Microbiologist role involves leading the development of SOPs and test method validations for microbiological analyses in a Class II medical device setting, transitioning the company’s QC testing in-house, and ensuring regulatory compliance. This position requires extensive experience in microbiological testing, method development, and laboratory management, with the capability to work independently in establishing and managing the QC function.

Schedule: 
Monday-Friday, standard working hours
 
Responsibilities:

• Write, revise, and implement Standard Operating Procedures (SOPs) and QC protocols for microbiological analyses.
  

• Lead the method development and validations for all analyses, such as LAL biopreservative, paraben, and bioburden testing.
  

• Conduct QC testing on incoming raw materials, preservatives, and finished product testing.
  

• Maintain and manage laboratory workflow, ensuring inventory, calibration, and proper operation of all lab equipment.
  

• Prepare and analyze reports from microbiological testing, ensuring regulatory compliance and accurate, timely communication of findings.
  

• Participate in internal/external audits and ensure regulatory adherence (GMP, FDA).

Qualifications:

• Bachelor’s or Master’s degree in Microbiology, Biology, or related field required.
  

• 5+ years of industry experience within a cGMP manufacturing cleanroom facility.
  

• Proven experience authoring procedures for microbiological analyses and performing test method validations on analyses, such as paraben, preservative, and bioburden testing (USP 61, 51).
  

• Knowledge and experience in environmental monitoring and Biosafety Level 1 and 2 laboratory protocols
  

• Knowledge of GMP and FDA regulations as applied to microbiology labs.
  

• Hands-on experience running and maintaining cultures.
  

• Startup experience strongly preferred.

 
What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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