For nearly a century, The Jel Sert Company has focused on creating high-quality,high-valuefoods and beverages that help bring people together. We are currently looking for a passionate and dedicated individual to join our team as a DIRECTOR OF QUALITY ASSURANCE. If you are looking for a work environment that encourages personal growth, responsibility, and a shared vision for creating incredible products that help create lasting memories, then Jel Sert wants you!
The Director of Quality Assurance will be responsible for all regulatory processes applicable to the organization's dietary supplement and medical food product lines while working closely with our senior management teams to ensure compliance with US FDA regulations as well as other state and local regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to the following:
- Oversee quality activities for the manufacturing and distribution of dietary supplements and medical foods in compliance with federal, state, and local regulations.
- Oversee the FDA regulatory process for dietary supplements and medical food products, including current Good Manufacturing Practices (GMPs) and interaction with FDA officials.
- Manage QA operations involving batch record creation, approval and management, production oversight, investigations, and change control.
- Manage operations (microbiological and analytical testing) of components, bulk materials, printed materials, reference standards, and finished products, encompassing overall formulations.
- Develops and maintains Standard Operating Procedures (SOPs) in support of the Quality Management System for dietary supplements and medical foods to ensure regulatory compliance.
- Manage the staffing and career planning of QA and QC management including hiring personnel as needed.
- Build out the regulatory affairs and quality teams and departments.
- Acts as the secondary SQF Practitioner.
- Develop and implement training programs.
- Hosts and executes 2nd and 3rd party audits and acts as the backup to the hosting regulatory audits.
EDUCATION and/or EXPERIENCE
- A seasoned professional with a minimum of 10 years of successful Quality Assurance experience within pharmaceuticals and/or dietary supplements and medical foods required.
- Minimum of 5 years of management experience required.
- Proven track record in implementing world-class quality systems
- Extensive experience with developing and implementing Quality Systems (ISO, FSSC, HACCP, SQF) and cGMPs for dietary supplements and medical foods.
- Excellent knowledge of laboratory procedures, manufacturing processes, and Quality/Food Safety audits.
- Co-Manufacturing experience is highly desirable.
- Bachelor's Degree with emphasis on Food Science, Microbiology, or Food Engineering, Chemistry or related scientific discipline.
KNOWLEDGE, SKILLS & ABILITIES
- Excellent written and oral communication skills required
- Strong organizational and project management skills
- Ability to multi-task, problem-solve, and be detail-oriented in a fast-paced environment.
- Proven ability to achieve goals through direct or indirect management of individuals or groups.
- Ability to communicate and interact effectively and professionally across functional groups and management levels as well as with vendors, customers, and third parties.
- First-rate leadership and management skills
- Proficient with Microsoft Office Suite (PowerPoint, Word, Excel, and Outlook)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Close Visual Acuity: to perform an activity such as: preparing and/or analyzing data and figures; viewing a computer terminal; extensive reading; visual inspection of lab work, paperwork, and computer work. This includes full-color perception, as the job involves organoleptic testing of products
- Standing: Remaining upright on the feet, particularly for sustained periods of time.
- Reaching: Extending hand(s) and arm(s) in any direction
- Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
- Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position to position.
- Fingering: Picking, pinching, typing, or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
- Grasping: Applying pressure to an object with the fingers and palm.
- Talking: Expressing or exchanging ideas by means of the spoken word.
- Hearing: perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
- Repetitive Motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
- Kneeling: Bending legs at knee to come to a rest on knee or knees.
- Crouching: Bending the body downward and forward by bending the leg and spine.
- Ability to lift up to 50 lbs on an as-needed basis
- Ability to climb stairs in order to get to areas of the facility to perform job responsibilities.
- Pushing and pulling of carts, with product weighing up to 115lbs, on an as-needed basis.
- Close visual acuity to perform activities: preparing and analyzing data and figures, viewing a computer terminal, reading, visual inspection of materials, operating laboratory devices, etc.
- Medium work: Exerting up to 50 pounds of force occasionally, and/or up-to 20 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
- The worker is subject to atmospheric conditions: One or more of the following conditions that affect the respiratory system of the skin: Fumes, odors, dusts, mists, and exposure to allergens.
- Move within and between warehouse, production, and office facilities
- The worker is subject to noise: There is sufficient noise to cause the worker to shout in order to be heard above the ambient noise level.
- The worker is subject to vibration: Exposure to oscillating movements of the extremities or whole body.
- The worker is subject to hazards: Includes a variety of physical conditions, such as proximity to moving machines, forklift trucks, and/or exposure to heat/humidity.
This is a safety-sensitive position based upon the exposure to running production machines and moving forklifts.
FOOD SAFETY, QUALITY RESPONSIBILITIES, and REQUIRED CERTIFICATION
- Responsibility for Food Safety and Food Quality
- Acts as back up to Vice President of Quality Assurance & Regulatory Affairs and QA/QC Managers.
- PCQI qualified (Preventive Control Quality Individual)
- Acts as the secondary SQF Practitioner
- Responsible for ensuring maintenance of product identity (GFCO, HALAL, KOSHER, and Organic Certified Products).
- Required certifications: SQF Practitioner, HACCP, and PCQ.
IMPACT ON JEL SERT
The job is essential to ensure that medical food and dietary supplement manufacturing operations are compliant with federal, state & local requirements.