PRODUCT DEVELOPMENT & REGULATORY COORDINATOR
Job Description
Mon - Fri
8 : 00 AM - 4 : 45PM
TITLE : Product Development & Regulatory Coordinator
POSITION OBJECTIVE : Responsible for assisting the Product Development & Regulatory Department on all tasks associated with the functionality and operation of the department.
QUALIFICATIONS :
- Five years of theoretical and practical experience in nutraceutical or pharmaceutical dietary supplements or related functions in a Nutraceutical or Pharmaceutical environment.
- Working knowledge of nutraceutical / pharmaceutical product development processes and techniques, including but not limited to good working understanding of formulation, piloting, testing techniques and systems, solid dosage equipment and dosage form development.
- Good knowledge of math, computer literacy, good written and oral communication skills, high degree of organizational skills and attention to detail.
- Associate or bachelor's degree in chemistry or other closely related field preferred.
- Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary.
- Capable of effectively managing job-related stress and fostering productive workplace interactions.
JOB RESPONSIBILITIES :
Perform data retrieval, data analysis and reporting using an applicable internal reporting system. Report any out-of-compliance items to management.Assist with the evaluation of new and alternate raw materials to improve current products and develop new products.Create or update raw materials specifications.Create or update packaging component specifications.Create or update finish product specifications.Create AS400 item numbers for Labels, Components, and Raw Materials.Prepare and submit pilot samples, new raw materials, and any analytical requirements the Product Development lab requires and follow up with QC Lab on results.Schedule and maintain pilot log, communicate with Sales team on pilot completion dates.Prepare and submit Purchase Requisition for raw materials needed to perform formulation pilots.Contact, build, and keep updated database of vendor information for each raw material / packaging component.Assist with regulatory requests and documentation requests for registrations, certificates of free sale and cGMP, and others.Communicate effectively and professionally with others at all levels of the organization and external contacts.Will be required to perform other duties as requested, directed, or assigned.Communicate daily with department management and provide detailed up-to-date reports on current, past, and upcoming projects.Communicate and update all the customers' needs and requirements, as needed.Maintain all required Standards of Quality throughout the entire process.Follow cGMP's, SOP's, MSDS specifications, Sampling and Formulation Plans, Safety in the Workplace Best Practices, OOS Best Practices, if and when applicable; adhere to safety policies and procedures at all times.Able to work independently or in a team to meet deadlines on all projects assigned.Identifies any deficiencies, constraints and / or problems that could hinder an efficient process flow and assist and / or provide ideas and feedback to solve them.Assist with creating Deviation Reports and Change Control.OTHER INFORMATION :
Ability to communicate clearly in both written and verbal formats.MACHINES, TOOLS, EQUIPMENT, ELECTRONIC DEVICES & SOFTWARE :
Proficient with MS Office Suite (Word, Excel, PowerPoint & Outlook)Florida Supplement is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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