Microbiology Specialist

Description

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 Betco 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 customer. Ensure all samples are processed in a timely manner. Operate, maintain and troubleshoot laboratory equipment. Manage inventory supplies and collections.

Microbiology-specific responsibilities, but not limited to:

• 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).

BEHAVIORAL CAPABILITIES:

Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practices, trends and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.

Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gain their trust and respect.

Integrity: Acts consistently with company values and the highest standards of ethical behavior.

Interpersonal Savvy: Relates well to all kinds of people, up, down, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Written/Verbal Communications: Is able to write & speak clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.

Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can negotiate with concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.

Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very top-line oriented; steadfastly pushes self and others for results.

Leading Edge: Constantly benchmarks “best practices” and expects subordinates to do the same. Strives to be as leading edge as appropriate in light of costs.

Organization/Planning: Plans, organizes, schedules, and budgets in an efficient, productive manner. Focuses on key priorities. Effectively juggles multiple projects. Anticipates reasonable contingencies. Pays appropriate attention to detail.

EDUCATION and REQUIRED SKILLS:

• 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

The ideal candidate will combine technical expertise in microbiology with a commitment to quality and regulatory compliance, supporting our team in maintaining the highest standards of product safety and efficacy