MICROBIOLOGIST II

Formulated Solutions Innovates, Formulates and Creates consumer brands. We put together a broadly talented team of experts in manufacturing, production, laboratory, regulatory, distribution and marketing, that possesses an unparalleled drive to deliver market-ready products of the highest quality. Our in-house technologies in Aerosol, Biochemistry, Cosmetic, Pharmaceutical and Polymer Chemistry, coupled with innovative package design and strategic marketing services, provides clients with one of the fastest design-to-market solutions in the world. We serve companies in pharmaceutical, cosmetic, personal care and specialty chemical applications. We also support small and large companies in generating and producing unique products for the retail market. Formulated Solutions offers a wide range of benefit options for our full-time employees, allowing them to find the right plan to enroll into. We also offer 401k with a company match and much more! If you are hard-working, self-motivated and looking for a new and exciting career opportunity, apply today! PRIMARY PURPOSE: The Microbiologist II executes a daily operational schedule within the Microbiology Laboratory and may perform special tasks on a limited basis, under oversight of the QA Director or Microbiologist III/IV, during the qualification and validation and/or verification of microbiological methodologies for in-process, QC batch release and stability sample testing of a wide range of potential biopharmaceutical products to include associated equipment and environment. MAJOR DUTIES AND RESPONSIBILITIES: • Adhere to a daily operational schedule of Microbiology Laboratory. • Ensure that all assays undertaken are adequately reported and prepare reviews of microbiological data, as required. • Ensure compliance of test procedures, as well as assist in maintaining records necessary for quality control, to include trending charts, statistical analyses and reports. • Limited assistance in the qualification and validation of in-house testing methods and protocols. • Provide assistance in the investigation of out-of-specification/out-of-limits test results and propose corrective action(s), as appropriate. • Identify, isolate and study micro-organisms, bacteria and their byproducts. • Ensure testing is performed accurately and in compliance with GLP, GMP, USP/EP, ISO, SOP and other approved test methods. • Assist in peer-training of Microbiologist I in aseptic and general microbiological techniques. • Maintain adequate inventory control of media, reagents, etc., as required for laboratory operations. • Participate in other activities as assigned by the Quality Assurance Director. QUALIFICATION: A. Required • Must have three (3) to six (6) years direct microbiology lab experience in FDA-regulated biotechnology, pharmaceutical or medical device industry. • Working knowledge of microbiology activities (cGMP, cGLP, cGDP) in a biotechnology, pharmaceutical or medical device environment. • Performs a variety of tasks. • May review the work of others. • Must be able to work in a fast paced environment and have a positive attitude. • Working knowledge and application of microbiological concepts, practices, and procedures in the analysis of pharmaceutical/biopharmaceutical products, including but not limited to: • Aseptic Microbiological principles • Microbial identification – Gram staining, API • USP Water collection and testing • USP and Microbial limit testing • Environmental Monitoring. B. Preferred Additional • Knowledge of investigation concepts within a cGMP quality system: • Non Conformance's • CAPA • Out of Specification • Deviations • Good interpersonal skills CRITICAL SKILLS AND ABILITIES: • Computer and communication skills, both verbal and written. • Focus on continuous improvement - ability to evaluate systems to improve system functionality and efficiency. • Relies on limited experience and judgment to plan and accomplish goals. • A certain degree of creativity and latitude is expected. • Works under general supervision. • Ability to work independently on routine tasks. COMPUTER SKILLS: • Microsoft Excel, Access, Word experience required • Manual dexterity • Able to carry and/or lift up to 30 lbs. • Able to withstand standing long periods (>1 hour) EDUCATION AND/OR TRAINING: • Associate’s in Microbiology or other applicable biological science (required) • Bachelor’s degree in Microbiology (preferred)

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