Position Summary: The QC Micro Lab Analyst (GMP/FDA – Cosmetics & OTC) is responsible for performing microbiological testing and supporting Quality Control activities in compliance with FDA regulations (21 CFR Parts 210/211), cGMP, and applicable compendial standards (USP, AOAC, ISO, FDA BAM).  

Key Responsibilities:

Microbiological Testing & Analysis

• Perform microbiological testing on raw materials, in-process, bulk, stability, and finished cosmetic, skincare, and OTC products in compliance with USP, FDA BAM, AOAC, PCPC methods, and internal SOPs.
• Conduct testing for the presence, enumeration, and identification of microorganisms including bacteria, yeast, mold, and algae.
• Monitor microbial growth, cultures, and laboratory samples, including identification and documentation of results.
• Apply microbiological practices in alignment with FDA regulations and Cosmetic GMP requirements, leveraging experience with cosmetic and skincare products in regulated environments.
• Perform microbiological techniques including Gram staining, endospore staining, catalase and oxidase testing.
• Demonstrate proficiency in aseptic techniques and sterility practices.

Laboratory Operations & Equipment

• Maintain laboratory operations including media preparation, culture handling, glassware, and consumable inventory.
• Assist in scheduling and coordinating maintenance and calibration of laboratory equipment.
• Maintain experience with laboratory equipment including incubators, laminar flow hoods, biosafety cabinets, autoclaves, microscopes, colony counters, DI water systems, and sterilizers.
• Perform or assist with instrument calibration, verification, and logbook review.
• Ensure proper documentation and compliance for laboratory systems and equipment.
• Support environmental monitoring programs and cleanroom practices (ISO Class 7/8) where applicable.

Quality, Compliance & Investigations

• Review testing requirements with R&D and Production, and schedule/prioritize sample workload from manufacturing and stability programs.
• Support and participate in Out of Specification (OOS), Out of Trend (OOT), and deviation investigations.
• Perform root cause analysis and contribute to Corrective and Preventive Actions (CAPA).
• Assist in drafting Non-Conformance Reports (NCRs) and reviewing batch records to determine potential causes and impact.
• Support process validation, method verification, and equipment qualification (IQ/OQ/PQ) activities.
• Maintain compliance with data integrity, safety, and regulatory requirements.

Collaboration & Communication

• Interact with QA/QC, Production, Warehouse, Engineering, R&D, Sales, and external customers/contractors.
• Collaborate with colleagues to troubleshoot issues, discuss additional testing, and evaluate equipment performance.
• Communicate testing status, priorities, and results to ensure timely product release and issue resolution.
• Assist Supervisory Microbiologist in workload prioritization and staffing needs.

Training & Safety

• Assist in the training of new microbiology laboratory personnel.
• Support quality audits and environmental health & safety programs.
• Assist in management of chemical hygiene programs and laboratory safety compliance, including handling of biohazardous materials and blood-borne pathogens.

Qualifications (Required)

• Bachelor’s degree in microbiology (required)

• 3–5 years of experience in pharmaceutical, OTC, or cosmetic microbiology testing in a GMP/FDA-regulated microbiology laboratory.
• Hands-on experience with Incubators, Laminar Flow Hoods, Biosafety Cabinets, Autoclaves, Compound Microscopes, Colony Counters, DI Water Systems, Media, Cultures, Standards, Sterilizers, and micro identification techniques.
• Strong documentation skills and attention to detail.
• Ability to analyze data and troubleshoot issues.
• Strong organizational and problem-solving skills.
• Ability to teach and train employees.
• Proficient math skills.
• Ability to lift and carry up to 10–15 pounds.

Preferred

• Knowledge of Environmental Monitoring programs.
• Knowledge of Microbial challenge testing.
• Familiarity with LIMS (Laboratory Information Management Systems).

Compensation & Benefits

Benefits

• Medical, Dental, Vision, Life/AD&D Insurance
• Supplemental Life/AD&D Insurance
• Paid Time Off (PTO)
• Special Paid Leave for employees’ personal events
• Company Paid Holidays
• 401(k) with employer match
• Year-End Gift