Microbiologist

Position Overview

We are seeking a highly motivated, detail-oriented, and experienced Microbiologist to join our pharmaceutical manufacturing facility. The Microbiologist will play a critical role in supporting the manufacture of OTC pharmaceutical products by performing microbiological testing, environmental monitoring, water testing, method suitability and verification studies, and quality control activities in accordance with FDA regulations, current Good Manufacturing Practices (cGMP), USP standards, and company procedures.

The ideal candidate will have hands-on pharmaceutical microbiology experience and the ability to independently perform laboratory testing, investigate microbiological issues, maintain accurate documentation, and contribute to the development and improvement of laboratory procedures.

Key Responsibilities

• Perform routine microbiological analyses using established laboratory procedures and validated/verified methods.
• Perform microbiological testing of raw materials, in-process samples, finished products, and other samples as required.
• Perform water testing and environmental monitoring, including sampling, testing, documentation, and evaluation of results.
• Perform method suitability studies and method verification for new product formulations in accordance with applicable USP requirements.
• Perform and/or support microbiological testing, including microbial enumeration, specified microorganisms, microbial identification, sterility testing, and endotoxin testing, as applicable to the laboratory's scope.
• Prepare samples, media, reagents, and solutions required for microbiological testing.
• Perform growth promotion and other required controls for microbiological media and testing.
• Analyze, document, and report laboratory results accurately and in a timely manner.
• Maintain complete and accurate laboratory records, worksheets, logbooks, test results, and other quality documentation.
• Analyze data generated from research and development projects and present findings to management and relevant team members.
• Assist with investigations, troubleshooting, deviations, out-of-specification (OOS) results, and environmental monitoring excursions.
• Collaborate with Quality Control, Quality Assurance, Production, and other departments to resolve microbiological and laboratory-related issues.
• Assist in the development, review, revision, and implementation of Standard Operating Procedures (SOPs) and laboratory procedures.
• Operate, maintain, and perform routine calibration or verification of laboratory equipment, including autoclaves, incubators, microscopes, pipettes, and other microbiological equipment.
• Ensure laboratory activities are conducted in accordance with FDA requirements, cGMP, USP standards, safety requirements, and company procedures.
• Maintain a clean, organized, and controlled microbiology laboratory environment.
• Support laboratory audits and inspections by maintaining appropriate documentation and ensuring laboratory practices remain inspection-ready.
• Stay current with developments in pharmaceutical microbiology, microbiological testing methods, USP requirements, and regulatory expectations.

Qualifications

Education

• Master's or Ph.D. degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or a related scientific field preferred.
• Bachelor's degree in a relevant scientific discipline may be considered based on applicable pharmaceutical microbiology experience.

Experience

• Minimum 1–2 years of hands-on microbiology laboratory experience, preferably within a pharmaceutical, OTC, medical device, cosmetics, or other regulated manufacturing environment.
• Experience working as an independent microbiologist, rather than solely in an assistant or support capacity, is strongly preferred.
• Experience with microbiological testing of pharmaceutical or OTC products is highly desirable.

Knowledge & Technical Skills

• Working knowledge of FDA regulations, cGMP requirements, USP standards, and ISO/IEC 17025 principles.
• Hands-on experience with microbiological testing methods, including:
• Microbial enumeration
• Specified microorganism testing
• Microbial identification
• Sterility testing
• Bacterial endotoxin testing
• Environmental monitoring
• Pharmaceutical water testing
• Method suitability and verification
• Growth promotion testing
• Strong understanding of aseptic techniques and contamination control.
• Proficiency in operating laboratory equipment such as autoclaves, incubators, microscopes, analytical balances, and pipettes.
• Ability to prepare and handle microbiological media, reagents, and laboratory samples.
• Strong understanding of laboratory safety and microbiological laboratory practices.
• Experience with laboratory documentation, investigations, deviations, OOS/OOT results, and CAPA is preferred.
• Experience with LIMS and Microsoft Office, particularly Excel and Word.

Core Competencies

• Strong attention to detail and accuracy.
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to interpret microbiological data and identify potential trends or abnormalities.
• Ability to work independently and make sound laboratory decisions within established procedures.
• Ability to work effectively as part of a cross-functional team.
• Strong commitment to data integrity, laboratory compliance, and product quality.
• Ability to manage multiple laboratory activities and meet testing deadlines.

Compliance & Quality Expectations

The successful candidate will be expected to maintain the highest standards of data integrity, laboratory practices, documentation, and regulatory compliance. All testing and laboratory activities must be performed accurately, consistently, and in accordance with approved procedures, applicable USP requirements, cGMP, FDA regulations, and company quality standards.

Job Type: Full-time

Work Location: In person

Pay: $20.00 - $25.00 per hour

Expected hours: 40.0 per week

Work Location: In person