Microbiologist

Microbiologist

Department: Quality Control – Microbiology

Reports To: Director of Quality / QC Manager

FLSA Status: Exempt

About Belleview Biosciences, LLC

Belleview Biosciences is a trusted contract manufacturer specializing in over-the-counter (OTC) and prescription pharmaceuticals. As a DEA-licensed facility and prescription repackager, we uphold the highest regulatory and quality standards to provide safe, effective, and compliant pharmaceutical products. Our expertise extends across formulation, production, and packaging, ensuring efficient and reliable solutions for our clients. At Belleview Biosciences, we are dedicated to delivering high-quality products and supporting our partners with streamlined, cost-effective manufacturing services.

Position Summary

The Microbiologist is responsible for performing microbiological testing and environmental monitoring to ensure the quality, safety, and compliance of pharmaceutical products and manufacturing environments. This position supports Quality Control activities through routine microbiological analysis of raw materials, water systems, environmental samples, utilities, in-process materials, and finished products in accordance with FDA regulations, cGMP requirements, USP guidelines, and company procedures.

The Microbiologist plays a critical role in maintaining the sterility assurance and contamination control program while supporting investigations, validations, and continuous improvement initiatives.

Essential Duties and Responsibilities

• Perform routine microbiological testing of:
• Raw materials
• Finished products
• In-process materials
• Stability samples
• Water systems (Purified Water and Water for Injection)
• Utilities including compressed gases
• Conduct Environmental Monitoring (EM) of classified manufacturing areas including:
• Viable air sampling
• Non-viable particle monitoring
• Surface monitoring
• Personnel monitoring
• Perform microbial identification using approved laboratory methods.
• Conduct microbial enumeration and microbial limits testing.
• Perform sterility testing in accordance with USP <71>.
• Conduct bacterial endotoxin testing using LAL methods.
• Perform bioburden testing.
• Prepare microbiological media and reagents.
• Perform growth promotion testing of microbiological media.
• Maintain microbial culture collections and reference organisms.
• Review microbiological data and ensure compliance with established specifications.
• Document laboratory activities following Good Documentation Practices (GDP) and ALCOA data integrity principles.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, and laboratory deviations.
• Participate in contamination investigations and root cause analysis.
• Support cleaning validation and disinfectant efficacy studies.
• Assist with method validation, method verification, and method transfer activities.
• Calibrate, qualify, and maintain microbiology laboratory equipment.
• Support internal audits, customer audits, and FDA inspections.
• Ensure compliance with cGMP, USP, FDA, ICH, and company SOPs.
• Maintain laboratory cleanliness and inspection readiness.
• Participate in continuous improvement and quality initiatives.
• Perform other duties as assigned.

Qualifications

Education

• Bachelor's degree in Microbiology, Biology, Biochemistry, or related Life Sciences discipline required.
• Master's degree is preferred but not required.

Experience

• 2–5 years of microbiology laboratory experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment preferred.
• Experience working under FDA cGMP regulations.
• Experience supporting aseptic manufacturing environments is preferred.
• Experience with Environmental Monitoring programs is highly desirable.

Required Knowledge, Skills & Abilities

• Strong understanding of microbiological laboratory techniques
• Knowledge of FDA cGMP regulations
• Familiarity with USP microbiology chapters including:
• USP <61>
• USP <62>
• USP <71>
• USP <85>
• USP <1116>
• Knowledge of contamination control strategies
• Understanding of aseptic processing principles
• Experience with Environmental Monitoring programs
• Strong analytical and troubleshooting skills
• Excellent documentation practices
• Ability to investigate microbiological deviations
• Strong organizational and time management skills
• Excellent verbal and written communication
• Ability to work independently and collaboratively
• Proficiency with Microsoft Office and Laboratory Information Management Systems (LIMS)

Preferred Technical Skills

Experience with one or more of the following:

• Sterility Testing
• Bioburden Testing
• Bacterial Endotoxin Testing (LAL)
• Environmental Monitoring
• Water System Monitoring
• Microbial Identification
• Media Preparation
• Growth Promotion Testing
• Gram Staining
• Membrane Filtration
• Incubator Qualification
• Cleaning Validation Support
• Disinfectant Efficacy Studies
• Aseptic Technique
• Data Integrity (ALCOA )
• Laboratory Investigations (OOS/OOT)

Physical Requirements

• Ability to stand for extended periods.
• Ability to lift up to 25 pounds.
• Ability to work within cleanroom and controlled environments.
• Ability to wear required Personal Protective Equipment (PPE), including sterile gowning.
• Manual dexterity to perform microbiological testing.
• Visual acuity for reading laboratory data and operating equipment.

Work Environment

• Pharmaceutical manufacturing facility
• Microbiology Quality Control laboratory
• Cleanroom and aseptic manufacturing environments
• Controlled environmental conditions
• Exposure to microbiological cultures, disinfectants, and laboratory chemicals
• Compliance with all safety, biosafety, environmental, and cGMP requirements

Key Performance Indicators (KPIs)

• Environmental Monitoring compliance and trend performance
• On-time completion of microbiological testing
• Right-first-time laboratory results
• Timely closure of microbiological investigations
• Accuracy and completeness of laboratory documentation
• Laboratory audit readiness
• Data integrity compliance
• Equipment calibration and preventive maintenance compliance
• Regulatory inspection readiness

Core Competencies

• Attention to Detail
• Scientific and Analytical Thinking
• Regulatory Compliance
• Problem Solving
• Integrity and Ethics
• Teamwork
• Communication
• Accountability
• Time Management
• Continuous Improvement
• Quality Focus

Equal Opportunity Employer

We are an Equal Opportunity Employer and are committed to creating an inclusive workplace where all employees are valued and respected. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law.