THE COMPANY: Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply. Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
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 <61> and <62> 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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