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TRC Talent seeks a full time Director, Regulatory Affairs for a leading manufacturer in the Lawrenceville area.聽
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Summary/Objective: Provide structure and leadership to Regulatory Affairs by ensuring that appropriate compliant processes, programs, and documentation are implemented and maintained.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
路 Lead and maintain Regulatory Systems to ensure compliance with 21CFR 111 and 117 regulations and 21 CFR 500 related to animal food.
路 Ensure all Quality pre-requisite programs (Food Defense, FSMA, HACCP, Vendor Qualification, Material Qualification, Stability Program, etc.) meet regulatory requirements.
路 Be a liaison with outside groups (3rd Party, FDA, USDA, etc..) regarding 21CFR 111 and 117
路 Lead customer, regulatory agency, and certification audits along with Director of Quality.
路 Lead the formal audit response and implementation of changes resulting from audit findings regarding SOPs and documentation, as well as their follow up CAPA.
路 Engage and complete client requests for documentation & information in a timely manner as needed.
路 Assist and consult internally with all departments regarding regulatory and quality assurance issues.
路 Development, train and establish KPIs
路 Continuous improvement in all aspects of work
路 Comply with all safety and SOP procedures
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Required Education, Skills and Experience
路 MS in Regulatory Affairs and/or BS in Chemistry, Biology or other directly related field of science
路 Prior experience in manufacturing pharmaceuticals, supplements, beverages, food and/or cGMP environment, prefer powder handling experience.
路 Prior experience with the creation and maintenance of prerequisite programs for FDA Code of Federal Regulations 21, in food and/or dietary supplement manufacture.
路 Experience with manufacturer declarations, material qualifications, international registrations, and regulation implementation.
路 Experience with certification management of quality programs such as: GMP (NSF/GFSI), Organic, Kosher, Halal, GFCO, NGPV, etc.
路 Strong communication, technical writing, and leadership skills
Certification required
路 Quality control programs such as GMP, NSF, SQF, ISO, Organic, Kosher, or similar certifications.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
Work Environment
This job operates in an office. This role routinely uses standard office equipment such as computers, calculators, phones, photocopiers, filing cabinets and fax machines. Awareness of lab environment, equipment and production is also required.
Essential Functions Cognitive (Reasoning)
Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Deal with non-verbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Deal with a variety of abstract and concrete variables. Comprehend complex, hard-to-understand concepts.
Essential Functions Mathematics
Make arithmetic calculations involving fractions, decimals, and percentages.
Essential Functions Communication (Speech & Composition)
Expression of a level to communicate fluently with employees, customers, and others in English to obtain and provide complex information. Vocalize and explain detailed data and problem-solve, both in-person and by telephone. Capable of interpretation of technical materials, oral presentation of reports and able to adapt vocabulary, tone, and content for listener.
Comprehension and expression of a level to draft lengthy technical documents such as project or research reports, and other advanced informational materials in English, requiring grammatical correctness and clarity of expression. Requires ability to compose narrative text and technical data that may vary according to the intended audience. Draft and edit quality papers, to prepare highly complex documents. May involve a large volume of such composition.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Employees will occasionally lift and carry up to 15 pounds, use peripheral vision and depth perception. Employees will frequently use well developed coordination simultaneously, read with attention to detail, see things near and far, able to distinguish basic colors and shades of colors and able to smell. Employees will continuously use fingers and both hands, sit for extended periods of time, and use routine hearing ability.
Environmental Factors:
The environmental factors described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Employees will occasionally be exposed to dust and working closely with others. Employees will frequently work alone. Employees will continuously work in an inside environment and be exposed to unusual fatigue factors due to viewing a computer screen continuously.
Travel
Moderate travel required - ability to travel occasionally for activities such as out-of-town meetings, training sessions or to travel to other VEI facilities.
TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
