Description
Microbiology Specialist
Bowling Green, OH
Day Shift
Direct Hire
$25-27 per hour
The Microbiology Specialist performs USP microbiology quality control testing on FDA Drug, FDA Cosmetic, EPA Disinfectant, and unregulated products. Collects tests, and records results on environmental samples within the facility to ensure the cleanliness of the facility. Other duties include preparation and maintenance of materials, equipment and assisting the Microbiology Team Lead in research and development efforts for the company and customers.
Requirements
- Ensure compliance with cGMP, GLP, and relevant ISO standards.
- Follow all microbiology related standard operating procedures and maintain accurate and detailed records of all testing activities.
- Participate in method validation and verification studies as needed.
- Assist in investigating out-of-specification (OOS) results and deviations.
- Support internal and external audits related to microbiology.
- Conduct microbiological testing on raw materials, in-process samples, and finished products.
- Perform environmental monitoring of manufacturing areas and utilities.
- Execute microbial identification using various methods and technologies.
- Conduct preservative efficacy testing and antimicrobial effectiveness testing according to United States Pharmacopeia (USP).
- Maintain clean and safe work environment.
- Maintain laboratory notebooks and electronic data in compliance with regulatory requirements.
- Participate in process improvement initiatives within the microbiology lab.
- Stay current with industry trends and new technologies in microbiology testing.
- Assist in the implementation of new methods and technologies as directed by the team lead.
- Perform all procedures to ensure the microbiology lab is functional for daily activities (sanitization/preparation of equipment, receipt of materials, etc.).
- Ensure laboratories are always clean and presentable to customers. Ensure all samples are processed in a timely manner. Operate, maintain and troubleshoot laboratory equipment. Manage inventory supplies and collections.
- Aseptic technique: utilize necessary techniques to ensure the sterility of testing along with monitoring for potential failure points that could be caused due to personnel or equipment contamination.
- Processes and procedures associated with USP.
- Prepare culture media, reagents, and other materials needed for testing.
- Dilution, culture plate propagation, purity/isolation plating, plate counts/enumerations, gram staining, and select microbial analysis screenings.
- Preparation and maintenance of cryopreserved organisms for all necessary lab testing.
- Write and revise Standard Operating Procedures (SOPs).
REQUIREMENTS:
- Bachelor's degree in Microbiology, Biology, or a related field; advanced degree preferred
- 0-3 years of experience in QC Microbiology, preferably in the pharmaceutical, cosmetic, or related industries
- Strong knowledge of microbiology techniques, including aseptic technique, microbial enumeration and identification methods
- Familiarity with FDA, EPA, and other relevant regulatory guidelines
- Must be able to collect samples from manufacturing tanks, raw material containers and bulk storage tanks
- Excellent attention to detail and strong analytical skills
- Good communication skills, both written and verbal
- Ability to work independently and as part of a team in a fast-paced environment
For immediate consideration, please forward your updated resume.
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