Microbiology Specialist

About the role

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 cleanliness. Prepares and maintains materials and equipment, and assists the Microbiology Team Lead in research and development efforts for the company and customers.

Responsibilities

• 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 a 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.
• Utilize aseptic techniques to ensure sterility of testing and monitor for potential failure points due to personnel or equipment contamination.
• Prepare culture media, reagents, and other materials needed for testing.
• Perform dilution, culture plate propagation, purity/isolation plating, plate counts/enumerations, gram staining, and select microbial analysis screenings.
• Prepare and maintain 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 the business; knows the competition; understands how strategies and tactics work in the marketplace.
• Customer Focus: Dedicated to meeting the expectations and requirements of internal and external customers; gathers first-hand customer information and uses it for improvements; acts with customers in mind; establishes and maintains effective relationships with customers to 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, both inside and outside the organization; builds appropriate rapport; uses diplomacy and tact; can diffuse high-tension situations comfortably.
• Written/Verbal Communications: Writes and speaks clearly and succinctly in a variety of settings and styles; ensures messages have the desired effect.
• Negotiating: Negotiates skillfully in tough situations with both internal and external groups; settles differences with minimal conflict; gains trust quickly; has a good sense of timing.
• Decision Quality: Makes sound decisions based on analysis, wisdom, experience, and judgment; solutions and suggestions are typically accurate; sought out by others for advice.
• Drive for Results: Consistently exceeds goals; is top-line oriented; steadfastly pushes self and others for results.
• Leading Edge: Constantly benchmarks “best practices” and expects the same from others; strives to be leading edge where appropriate in light of costs.
• Organization/Planning: Plans, organizes, schedules, and budgets efficiently; focuses on key priorities; effectively juggles multiple projects; anticipates reasonable contingencies; pays attention to detail.

Qualifications

• 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.
• Ability 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 the team in maintaining the highest standards of product safety and efficacy.