QC Specialist, Regulatory Science

Specialist, Regulatory Science (Microbiology/QC)

Mahwah, New Jersey

Contract | 12 months

Our client, a leading pharmaceutical company, is seeking a Regulatory Science Specialist to support onsite manufacturing operations, with a focus on the sterilization and cleanliness of medical devices. This role requires familiarity with cGMP, standard laboratory techniques (USP and ISO-based testing methods), and safety procedures (OSHA), along with solid grounding in scientific concepts, measurements, and terminology.

You’ll be responsible for performing routine testing (growth promotion, total organic carbon, etc.) and environmental monitoring in compliance with established procedures and regulatory requirements, including analyzing environmental and water samples, documenting and trending lab data, supporting OOS investigations, and assisting with data review. You’ll also help maintain lab equipment through calibration, preventive maintenance, and troubleshooting, while ensuring adequate supplies and quality control standards.

• Conduct routine microbiological lab testing and process monitoring in compliance with methods, procedures, protocols, and regulatory requirements
• Perform lab analysis of environmental and water samples, including microorganism identification per defined procedures
• Maintain accurate records and document results in accordance with GDP and established procedures
• Perform data entry for trending analysis
• Assist with review of worksheets as assigned
• Support investigation of OOS results within areas of assigned responsibility
• Operate and maintain lab equipment, including preventive maintenance, routine performance checks, and calibration; troubleshoot minor issues
• Maintain lab supplies, including order placement and QC checks
• Prepare solutions and mixtures

• Knowledge of medical devices, sterilization, aseptic technique, environmental monitoring, and microbiological QC testing/procedures preferred
• Excellent manual dexterity
• Ability to complete sampling/testing assignments in a timely, compliant manner with minimal supervision
• Ability to perform limited data interpretation
• Ability to manage multiple assignments simultaneously while meeting deadlines and compliance standards
• Knowledge of cGMPs and compendia testing required
• Strong verbal and written communication skills
• B.S. in Biological Sciences or related field, with 2+ years of QC microbiology lab experience preferred