Quality Control Scientist - Microbiology

Job Title: Quality Control Scientist - Microbiology
Job Location: Princeton, NJ
Job Duration: 4 Months on w2
Shift: Monday - Friday, 8:00 AM - 4:30 PM
Flexibility for overtime and occasional weekends as needed

Position Summary:

The QC Scientist - Microbiology, Bio-Analytical & Raw Material is responsible for performing microbiological, bio-analytical, and raw material testing to ensure product quality, safety, and compliance within a regulated pharmaceutical or biotechnology environment. This role supports routine testing of raw materials, in-process samples, and finished products, while also contributing to environmental monitoring, aseptic process control, and continuous improvement initiatives.

The QC Scientist will collaborate cross-functionally with Quality Assurance, Manufacturing, and Research & Development teams to investigate deviations, support CAPA and Change Control activities, and maintain compliance with cGMP and regulatory requirements. The role also includes mentoring junior staff, supporting audits, maintaining laboratory equipment, and ensuring operational excellence within the microbiology laboratory.

This position additionally supports raw material quality activities including material specifications, identification testing, assays, and impurity analysis according to established procedures and regulatory standards.

The QC Scientist reports directly to the Supervisor, Quality Control.

Key Responsibilities:

• Microbiology & Bio-Analytical Testing
• Perform sterility, endotoxin, microbial identification, and routine microbiological testing on raw materials, in-process samples, and finished products
• Conduct compendial testing including BacT assays, endotoxin testing, and Mycoplasma assays
• Perform growth promotion testing and support final product release activities
• Execute environmental monitoring for manufacturing and laboratory areas to support aseptic control programs
• Support EMPQ activities, cleaning and disinfection programs, and microbial control initiatives
• Data Analysis & Investigations
• Analyze and interpret microbiological and bio-analytical data in compliance with SOPs and regulatory requirements
• Perform trend analysis of environmental monitoring and sterility data and prepare monitoring reports
• Identify risks and recommend corrective actions or resolution plans
• Participate in investigations involving deviations, out-of-specification results, and non-conformances
• Support CAPA implementation, Change Control activities, and continuous improvement efforts
• Laboratory Operations
• Ensure laboratory equipment is calibrated, maintained, and operating properly
• Perform routine cleaning and maintenance of laboratory equipment including refrigerators, incubators, and biological safety cabinets
• Maintain laboratory inventory, reagents, documentation, and logbooks
• Support internal and external audits by providing required data and documentation
• Train and mentor staff on microbiological techniques, laboratory procedures, and aseptic practices
• Cross-Functional Collaboration
• Partner with Quality Assurance, Manufacturing, and R&D teams to support product quality and compliance initiatives
• Assist in developing and implementing microbial control strategies from raw material receipt through final product release
• Stay current with industry trends, microbiological advancements, and evolving regulatory requirements

Required Qualifications:

• Bachelor s or Master s degree in Microbiology, Biochemistry, Analytical Chemistry, Molecular Biology, or a related scientific field
• Minimum 4 - 7 years of experience in a microbiology and/or bio-analytical laboratory within pharmaceutical, biotechnology, or related industries
• In lieu of a degree, 10+ years of relevant laboratory experience may be considered
• Strong knowledge of microbiological and bio-analytical techniques including aseptic techniques, ddPCR, Flow Cytometry, ELISA, viability assays, and cell culture
• Experience with method development and validation in regulated environments
• Familiarity with FDA, EMA, and cGMP regulatory requirements
• Proficiency with laboratory instrumentation, testing procedures, and data analysis software
• Strong analytical, troubleshooting, and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a fast-paced environment
• Understanding of statistical analysis, quality systems, and continuous improvement methodologies

Preferred Skills:

• Experience supporting aseptic manufacturing environments
• Knowledge of environmental monitoring programs and microbial control strategies
• Experience participating in audits and regulatory inspections
• Strong organizational skills with high attention to detail and documentation accuracy