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  • Location: Rock Hill, South Carolina
  • Type: Direct Hire
  • Job #877

Currently seeking an experienced Microbiologist in the greater Charlotte, NC area.

Roles and Responsibilities:

  • The Quality Control Microbiologist reports to Quality Control (QC) Management. 
  • 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 (C of A’s).
  • Subject matter Expert (SME) to include but not limited to: microbial identification, probiotics, Environmental Monitoring (EM) risk evaluator, etc. 
  • Responsible for submitting sample to contract labs as necessary with appropriate documentation. Follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion. The analyst will be responsible for reporting the results of analyses on finished product Certificates of Analysis (COAs). 
  • 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 (OOS) laboratory data when necessary. 
  • Perform evaluation/ validation testing on finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and industry guidelines. (S)he will be responsible for the execution of Evaluation Protocols as well as Evaluation/Validation Reports and Summaries, following Current Good Manufacturing Practice (cGMP) documentation guidelines, to be presented to QC and Upper Management. 
  • Provide assistance in ensuring the lab and company current policies align with current USP, ISO, FDA, and NSF requirements.
  • Support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
  • Participate in  the proficiency testing program.
  • Provide guidance and methodologies for current and new microbiological processes.
  • Knowledgeable on the collection of Environmental Monitoring (EM) samples, following SOPs, as needed to meet the needs or goals of the company.  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 to QC,  Manufacturing, or Packaging Management, as appropriate. 
  • Support the  validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
  • Provide input for the improvement of existing SOPs, test methods, and other protocols and policies throughout the Micro Laboratory. (S)he will also be involved in implementing new procedures within the laboratory and the authoring of  new SOPs, as appropriate. 
  • Have good understanding of all equipment and methods used throughout the QCM Laboratory, including but not limited to the following instrumentation: Laboratory Balances, Soleris Rapid Microbiology Systems, Autoclave, Incubators, Stomacher, Microscope, and the Bio-Safety Cabinet. 
  • This individual will be  required to troubleshoot his or her own analyses or experiments, and to draw conclusions with sound scientific judgment. Assist other analysts in the laboratory with troubleshooting as problems arise with instrumentation or with other microbiological analyses. 
  • Assist in developing and executing test methods for the analysis and QC testing of microbiological media (Growth Promotion) for suitability and the interpretation of growth (organism identification) from samples and controls.
  • Assist in gathering information and data for product or situation investigations relevant to the QCM Laboratory or to Quality Control (QC) as a whole. 
  • Assist in training new laboratory personnel. All training performed under the supervision of the QCM will be documented in accordance with established SOPs and the training program.
  • Maintain a  safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
  • Provide assistance, as needed, to the Quality Laboratory within Chemistry with any  chemistry application of which (s)he is knowledgeable and trained. 
  • Regular attendance is required.
  • Must be able to effectively communicate with other department and function within a team environment.
  • Performance of other duties  may be required for meeting company goals.

    Minimum Requirements: Four or more years of laboratory experience in a cGMP facility, including experience with the proper operation of laboratory instrumentation, troubleshooting, and the generation and revision of SOPs. Effective interpersonal skills and the ability to interact with all levels of personnel are required. Equivalent combination of education and experience may be considered

    Education and Experience: A Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in Microbiology, or a related science, or a combination of experience and education deemed equivalent is required for the QCM II position.

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