Regulatory Science SpecialistLocation: Mahwah, New Jersey
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:- Supporting onsite manufacturing of orthopedic medical devices by ensuring the sterilization and cleanliness of the devices.
- Familiarizing with cGMP, standard laboratory techniques (i.e., USP and ISO based testing methods), and safety procedures (i.e., OSHA).
- Demonstrating knowledge of scientific concepts, measures, and terminology.
- Performing routine testing (e.g., growth promotion, total organic carbon) and environmental monitoring in compliance with established procedures and regulatory requirements.
- Analyzing environmental and water samples, documenting and trending laboratory data, supporting OOS investigations, and assisting with data review.
- Maintaining laboratory equipment through calibration, preventive maintenance, and troubleshooting, while ensuring adequate supplies and quality control standards are met.
- Conducting routine microbiological laboratory testing and process monitoring in accordance with methods, protocols, and regulatory requirements.
- Performing laboratory analysis of environmental and water samples and identifying microorganisms according to defined procedures.
- Maintaining accurate records of work performed and documenting results in accordance with GDP and established procedures.
- Performing data entry required for trending analysis.
- Assisting with the review of worksheets, as assigned.
- Supporting the investigation of OOS results within assigned responsibility areas.
- Operating and maintaining laboratory equipment, ensuring reliability through executing preventive maintenance, routine performance, and calibration checks; demonstrating the ability to troubleshoot minor issues.
- Maintaining laboratory supplies, including order placement and QC checks.
- Preparing solutions and mixtures for testing and analysis.
Qualifications: - Bachelors degree in Biological Sciences or a related field.
- Minimum of 2 years experience in a QC microbiology laboratory environment, particularly in regulated manufacturing settings such as medical devices or pharmaceuticals.
- Excellent manual dexterity and keen attention to detail.
- Proven ability to complete sampling and testing assignments accurately and efficiently.
- Strong understanding of cGMPs and compendia testing protocols.
- Effective verbal and written communication skills.
- Ability to handle multiple projects simultaneously with minimal supervision.
- Experience with routine microbiological testing, environmental monitoring, and analysis of water samples.
- Familiarity with laboratory safety procedures and equipment calibration.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company