Quality Control Microbiologist II

Roles and Responsibilities:

• The Quality Control Microbiologist II (QCM II) reports to Quality Control (QC) Management.
• The QCM will perform release testing on finished products following Standard Operating Procedures (SOPs) and in-house test methods.
• The QCM II will review and approve documentation to include but not limited to Data Control Reports, Notebooks, and Certificates of Analysis (C of A's).
• The QCM II will be assigned a specific area (determined by upper management) and become the Subject matter Expert (SME). This areas include but not limited to: microbial identification, probiotics, Environmental Monitoring (EM) risk evaluator, etc.
• The QCM II will be responsible for submitting sample to contract labs as necessary with appropriate documentation. The QCM II will 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).
• The QCM II will be 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. (S)he will initiate Investigation reports for out of specification (OOS) laboratory data when necessary.
• The QCM II will perform evaluation/ validation testing on Nutramax Laboratories, Inc. 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.
• The QCM II will provide assistance in ensuring the lab and company current policies align with current USP, ISO, FDA, and NSF requirements.

• The QCM II will support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
• The QCM II will participate in the proficiency testing program.
• The QCM II will provide guidance and methodologies for current and new microbiological processes.
• The QCM II will be knowledgeable of the collection of Environmental Monitoring (EM) samples, following QCM SOPs, as needed to meet the needs or goals of the company. (S)he will 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. The QCM II will be responsible for the scrutiny, documentation, and interpretation of EM results. (S)he must communicate EM trends and findings to QC, Manufacturing, or Packaging Management, as appropriate.
• The QCM II will support the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
• The QCM II will 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.
• The QCM II will have a 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. The QCM II will also assist other analysts in the laboratory with troubleshooting as problems arise with instrumentation or with other microbiological analyses.
• The QCM II will 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.
• The QCM II will assist in gathering information and data for product or situation investigations relevant to the QCM Laboratory or to Quality Control (QC) as a whole.
• The QCM II will 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 Nutramax Laboratories, Inc. training program.
• The QCM II will maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
• The QCM II will 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: The QCM II will have 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.

Supervisory Responsibilities: None