QC Micro Lab Analyst (GMP/FDA – Cosmetics & OTC)
United States
Full Time
Experienced
Title: QC Micro Lab Analyst (GMP/FDA – Cosmetics & OTC)
Reports to: Director of Quality Control
Department: Quality Control
Location: Totowa, New Jersey (Onsite, Full-Time)
Schedule: Monday–Friday, Five Days Per Week
This role ensures the microbiological quality of raw materials, in-process, and finished cosmetic, skincare, and OTC drug products, while maintaining data integrity, audit readiness, and regulatory compliance. The analyst will actively support investigations, CAPA, and continuous improvement initiatives in a GMP-regulated environment.
Reports to: Director of Quality Control
Department: Quality Control
Location: Totowa, New Jersey (Onsite, Full-Time)
Schedule: Monday–Friday, Five Days Per Week
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).
This role ensures the microbiological quality of raw materials, in-process, and finished cosmetic, skincare, and OTC drug products, while maintaining data integrity, audit readiness, and regulatory compliance. The analyst will actively support investigations, CAPA, and continuous improvement initiatives in a GMP-regulated environment.
Key Responsibilities:
The QC Micro Lab Analyst is responsible for supporting the company’s business events through a variety of tasks, including: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
Pay Range: $60,000 to $85,000 per year (commensurate with experience)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
Englewood LAB is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
Apply for this position
Required*