Regulatory Specialist

Job Title: Regulatory Science Specialists

Location: Mahwah NJ

Schedule: Onsite

Contract: 12 months to start with potential for extension

Pay Rate: $41/hr

***Due to client requirements this role is only open to USC or GC candidates only on W2***

Position Overview:

Support onsite manufacturing of orthopedic medical devices pertaining to the sterilization and cleanliness of the devices. Familiar with cGMP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA). Knowledgeable in scientific concepts, measures, and terminology. Responsible for performing routine testing (i.e., growth promotion, total organic carbon) and environmental monitoring in compliance with established procedures and regulatory requirements. Conducts analysis of environmental and water samples, documents and trends laboratory data, supports OOS investigations, and assists with data review. Maintains laboratory equipment through calibration, preventive maintenance, and troubleshooting, while ensuring adequate laboratory supplies and quality control standards are maintained.

Responsibilities:

• Conduct routine microbiological laboratory testing and process monitoring in compliance with methods, procedures, protocols, and regulatory requirements.

• Perform lab analysis of environmental and water samples and identification of microorganisms according to defined procedures.

• Maintain accurate records of work performed, document results in accordance with GDP and established procedures.

• Perform data entry required for trending analysis.

• Assist with review of worksheets, as assigned.

• Assist in the investigation of OOS results in areas of assigned responsibility.

• Operate and maintain laboratory equipment, ensuring reliability through execution of preventive maintenance, routine performance and calibration checks; demonstrate ability to troubleshoot minor issues.

• Maintain laboratory supplies including order placement and QC checks.

• Prepare solutions and mixtures.

Qualifications:

• Knowledge of medical devices, sterilization, aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures preferred.

• Has excellent manual dexterity.

• Has ability to complete sampling or testing assignments in a timely and compliant manner, with minimal supervision.

• Perform limited interpretation of data.

• Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision.

• Knowledge of cGMPs and compendia testing required.

• Must have effective verbal and written communication skills.

• B.S. degree in Biological Sciences or related field with minimum of 2 years of QC microbiology laboratory experience preferred.