Job Description

PRIMARY PURPOSE:

• Adhere to a daily operational schedule of Microbiology Laboratory.

• Conduct testing on in-process samples, QC batch releases, raw materials, and stability samples.

• 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.

• Isolate, characterize, and identify microorganisms as needed.

• 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 Microbiology Laboratory Management or a senior Microbiologist III (Microbiologist III or higher).

QUALIFICATION:

• 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.
• Proficiency in using laboratory equipment and software (i.e., LIMS).
• Working knowledge and application of microbiological concepts, practices, and procedures in the analysis of pharmaceutical, OTC, and cosmetic products, including but not limited to:
• Aseptic microbiological principles
• Microbial characterization- Gram staining
• USP Water collection and testing
• USP <51> , <60> , <61> and <62>
• Environmental monitoring

Preferred Additional

• Knowledge of investigational concepts within a cGMP quality system:
• Non-Conformances
• 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.
• Collaboration and Teamwork: Willingness to work closely with team members and contribute to collective efforts. This involves being open to different perspectives, brainstorming solutions together, and supporting team decisions.
• Works under general supervision.
• Ability to work independently on routine tasks.

COMPUTER SKILLS:

• Microsoft Excel, Access, Word experience required.
• Manual dexterity

EDUCATION AND/OR TRAINING:

• Associate degree in microbiology or other applicable biological science is required.
• Bachelor's degree in microbiology, biology, or a related field is preferred.

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