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Quality Control Microbiologist

Lancaster, SC

IDNC107-2745885Posted 6/16/2025

The Quality Control Microbiologist will perform release testing on finished products following Standard Operating Procedures (SOPs) and in-house test methods.
Review and approve documentation to include but not limited to Data Control Reports, Notebooks, and Certificates of Analysis.
Microbial identification, probiotics, Environmental Monitoring risk evaluator, etc.
Responsible for submitting samples to contract labs as necessary with appropriate documentation.
Follow Current Good Manufacturing Practice documentation guidelines to record all procedures in a timely fashion.
Responsible for reporting the results of analyses on finished product Certificates of Analysis.
Responsible for the documentation of all routine and non-routine microbiological testing performed on raw materials, finished products, and special request samples whether performed in-house or by the certified contract laboratory.
Initiate investigation reports for out of specification laboratory data when necessary.
Perform evaluation/ validation testing. Finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and industry guidelines.
Responsible for the execution of Evaluation Protocols as well as Evaluation/Validation Reports and Summaries, following Current Good Manufacturing Practice (cGMP) documentation guidelines
Provide assistance in ensuring the lab and company current policies align with current requirements.
Support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
Provide guidance and methodologies for current and new microbiological processes.
Knowledgeable of the collection of Environmental Monitoring (EM) samples, following Quality Control Microbiologist SOPs, as needed to meet the needs or goals of the company.
Be familiar with the operation of both the APC Airborne Particle Counter and the SAS Air Sampler and will be proficient in the use and handling of media plates for EM sampling.
Responsible for the scrutiny, documentation, and interpretation of EM results.
Communicate EM trends and findings.

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