Microbiologist Roles and Responsibilities: Perform release testing on finished products following Standard Operating Procedures and in-house test methods. Responsible for submitting samples to contract labs as necessary with appropriate documentation. 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). Responsible for the documentation of all routine and non-routine microbiological testing performed on raw materials, finished products, and special request samples weather performed in-house or by the certified contract laboratory. (S)he will initiate Investigation reports for out of specification (OOS) 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. (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. Knowledgeable of the collection of Environmental Monitoring (EM) samples, following 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. 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. 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. Review and sign off on reports and Certificates of Analysis (C of As) generated by other QC personnel.
Have a good understanding of all equipment and methods used throughout the Laboratory, including but not limited to the following instrumentation: Laboratory Balances, Biolumix Rapid Microbiology Systems, Autoclave, Incubators, Stomacher, Microscope, and the Bio-Safety Hood. This individual will be required to troubleshoot his or her own analyses or experiments, and to draw conclusions with sound scientific judgment. The Quality Control Microbiologist will also 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 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.
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 QC Chemistry Laboratory with any chemistry application of which (s)he is knowledgeable and trained. 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: Two 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. Education and Experience: A Bachelor of Sciences (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 position.