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Job Description
SUMMARY The Microbiologist supports and maintains product quality by being a key contributor in conducting, and reviewing microbiologic tests, applying concepts, practices, and procedures within the microbiology/sterile field and communicating results as a Microbiology Subject Matter Expert (SME). The Microbiologist will work with 503A operations. This is an on-site position in Ocala, FL.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Performs and reviews accurate release testing according to established SOPs, including but not limited to, sterility and endotoxin, visual inspection, etc. Write/Review SOPs and Change Controls Perform Environmental Monitoring of the cleanroom areas. Perform testing in conjunction with laboratory investigations. Draft microbiological reports, including but not limited to; Environmental Action reports, Protocols, Studies, Out of Specification Reports, Summary reports, etc. Review and report data ensuring precise and accurate testing is performed. Participate in method development and validation, if requested Ensure that all sterile products are tested following regulatory requirements such as but not limited to: USP <795> & <797>, cGMP Sample result reading and data interpretation Maintain documentation. Review, trend and report environmental, personnel, in process, raw material, and finished product microbiological testing results. Perform and review various microbiological procedures such as media qualifications, sterilizations, growth promotion tests and identification tests Recognize, report and investigate any aberrant (Out of specification) test and/or sample conditions. Maintain historical files on organisms found in classified areas; microbial identification and trending. Support laboratory activities like media preparation, monitoring of incubators, refrigerators, etc. Actively participate in investigations as microbiology Subject Matter Expert (SME) Maintain and Manage the ATCC culture collection Prepare and send samples for microbiological identification Inspect, and review media fills and associated data Keep informed of current scientific principles and theories Initiate, complete and/or review OOS or Environmental Monitoring Excursion Investigations Provide support of general QC Microbiology Laboratory activities such as; chart reading and changing, equipment cleaning and maintenance, maintain supplies and inventory and general laboratory housekeeping Other duties may be assigned by management.
QUALIFICATIONS AND SKILLS
Bachelor's degree in Biology, Microbiology or appropriate discipline with at least 2-years experience, preferred. Experience with OOS investigations/deviations/Non conformances, preferred. Understanding of USP and Experience using aseptic techniques in GMP environment, preferred Experience in reports for findings from FDA and state pharmacy board inspections. Knowledge of different substances from small molecules to peptide, preferred. Willing to travel 10 - 20% to other WPN sites. Strong critical thinking skills Excellent written and verbal communication skills Strong leadership skills Ability to multi-task and ensure deliverables are completed within designated time frame Comfortable with public speaking Excellent interpersonal skills Any ASQ certification, preferred. Knowledge of pharmaceutical regulations Understanding of GMP requirements Strong microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment is required. Knowledge of sterility methods; gamma, heat, chemical and/or filtration Familiarity with Rapid Microbiological Detection methods, preferred
Job Type:
Full-time Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Vision insurance Application Question(s): Do you have stron microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment? Required Do you have a BS in Microbiology/Biology/Biochemistry or related sciences? Do you have at least 2 - 3 years' experience with gram stains, sub-culturing and identification of microorganisms and environmental monitoring? Do you have experience with current practices and procedures used in microbiological and analytical laborator? Do you have hands-on experience with microbiological investigations ? Do you have good understanding of USP guidelines (<71>, <797>, <795>, <800>, <61>, <62>, <51>)? Do you have good understanding of FDA Good Manufacturing Practices Regulations (GMP's), USP and OSHA safety requirements? Do you have communication (both written and oral), interpersonal, team building and organizational skills?
