QC Microbiologist II

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Candidate must demonstrate strong technical understanding of methodology and systems of quality testing, scientific principles and practices. Specific duties for the position to include analytical testing, providing input for projects, training of other employees, knowledge of laboratory and manufacturing systems, troubleshooting, Document creation and maintenance, material sampling, environmental monitoring, media production and growth promotion, water testing, raw material testing, microbial identification and other duties as required. Provide daily analytical testing support under little supervision. Collaborate with senior and associate members on method development and validation projects. Provide training of other employees on technical, cGMP, safety and administrative aspects of job. Serve as a informational/troubleshooting resource for laboratory and pharmaceutical manufacturing systems. Support creation, revision and maintenance of documents including SOPs, methods, protocols and reports. Carry out sampling of purified and potable water systems using aseptic technique. Perform environmental monitoring of manufacturing and support areas using SAS volumetric and contact plate test applications. Drive production of microbiological media including materials autoclaving, broth/agar medium production, nutritional adequacy/growth promotion culturing, pH assessment and inventory management. Execute TOC, conductivity and microbiology assessments of water systems, employing on-line and manual methodologies, Standard Methods membrane filtration and colony enumeration. Perform Microbial Limits Testing of raw materials and products per USP methodology including total aerobic/yeasts and molds quantitative methodology and qualitative organism presence/absence tests and perform preparatory testing/suitability of the test method. Carry out identification of microbial isolates via traditional staining and culturing techniques and Vitek ID systems. Lead in laboratory investigation process related to OOS, OOT results. Drive input for continuous improvement activities (LEAN, 5S) through participation intra and interdepartmentally. Leads consistently in productivity, quality and teamwork metrics.QualificationsBS, BA or Associates degree in sciences or related field.Required minimum 3 years of related experience. Must be able to lift up to 25 pounds, walk or remain standing for up to 4 hours at a time, wear a respirator for up to 1 hour at a time.Good written, verbal and electronic communication skills are a must. Job requires the candidate must perform duties in tight accordance with all applicable written procedures, guidelines and current Good Manufacturing Practices (cGMP). Thoroughness and attention to detail in the performance, reporting, documentation and completion of all tasks are an expectation. Must work well in a team environment.
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