Regulatory Specialist - McBride Research Labs
Advance American Laboratories a subsidiary of McBride Research Laboratories is seeking a Regulatory Specialist. The purpose of the Regulatory Specialist role is to support the plant quality programs and regulatory programs for cosmetic hair care products. Primary responsibility includes working closely with production and manufacturing technicians to maintain the highest quality for our products and to ensure products are within applicable specification and standards. Responsible for regulatory affairs including audit reports, regulatory reporting and overall enforcement.
• Perform QC testing on raw materials and finished products (including but not limited to pH, viscosity, specific gravity, % solids, micro and fill weight determination)
• Complete and maintain the documentation and reports pertaining to manufactured batches and lab prototypes
• Prepare the Ingredient listings for new and reformulated products
• Review artwork labels for accuracy
• Assist R&D and Production staff with other tasks as needed
• Prepare dossiers and documentation for CAN/EU per international regulations
• Complete WERCSmart product registrations
• Liaise with contract laboratories for product challenge testing and safety testing
• Maintain Formulator™ Software
• Communicate with contract manufacturers regarding products
• Maintain documentation of all processes and procedures Physical Requirements:
• Ability to tolerate sustained standing/walking up to 10 hours a day.
• Ability to perform occasional to frequent lifting of up to 30 lbs.
• Ability to utilize good eye-hand coordination.
• Ability to perform occasional bending and squatting.
Required Experience, Skills, and Education:
• Must have a Bachelor’s Degree and/or Master’s in Chemistry, Biology, microbiology or any related scientific discipline.
• 2 to 5 years related experience working in quality department, cosmetic, and/or in a manufacturing environment or any similar industry in Quality Control and/or Regulatory.
• Knowledge of cosmetic label requirements Statistical Process Control process/principles
• Knowledge of quality control and regulatory protocols and procedures.
• Experience with Good Manufacturing Practices (GMP), Hazard Analysis Critical Control Points (HACCP), FDA, OSHA and State regulations related to cosmetic and manufacturing
• Ability to understand instructions, work procedures, reason and make judgments, problem solve, plan, coordinate, and direct own work while coping with a variety of duties and expectations.
• Ability to communicate clearly and distinctly (oral and written) with peers and supervisors.
• Ability to perform effectively under stressful conditions, prioritizing job duties while working with team members.
• Strong analytical and problem solving skills, making good decisions quickly without direct supervision.
• Proficient in Microsoft Office applications; Word & Excel.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
• Ability to compute rate, ratio, and percent and interpret bar graphs
• Ability to write routine reports and correspondence
• Shows correct sense of urgency to find and fix all abnormalities and other operating issues.
• Treats safety and housekeeping as a non-negotiable
• Perform/ Ensure all required safety and housekeeping audits
• Identify safety issues and immediately implement countermeasures, involving the right resources
• Promote a safe working environment and assist in departmental hazardous waste management process.
• Follow plant and department safety practices, emergency response procedures
• Ensure all other safety goals of the team are met
• Treats quality as a non-negotiable
• Ensure all required quality checks are completed
• Ensure hold procedure is completely followed during each hold event
• Inspect batches and finish product using applicable testing methods
• Keep detail and accurate records of completed batches, tests, inspections, audits
• Communicate quality issues to the right resources and respond in a timely fashion