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Regulatory Compliance Specialist I
2 weeks ago
At Prinova, our passion for food knows no bounds With a rich history spanning over four decades in the food industry, we have established ourselves as a trusted global supplier and manufacturer of functional food ingredients, flavors, and aromas.
_With CUSTOMER FOCUS as our central core value, we put pride in our work to ensure the end user has a quality product.
_- Prinova has proudly received national acclaim as one of the Best and Brightest Companies to Work For in 2023, a testament to our status as an exceptional employer. This prestigious award highlights our commitment to outstanding HR practices and appreciation for our employees. Guided by the renowned FISH philosophy, we prioritize creating meaningful work interactions, fostering community engagement, and empowering professional growth, ensuring a remarkable and fulfilling experience for our team members._
Regulatory Compliance Specialist I
Department:
Quality/Regulatory, Solutions
Location:
Carol Stream
Type:
Full Time**- This position supports the Solutions Regulatory group on activities associated with Raw Material Data Management, Food and Dietary Supplement Regulations.
It also provides technical insight to help determine company decisions associated with product labeling, raw materials database management and new product launches based on knowledge of current FDA Code of Federal Regulations (CFR), current Good Manufacturing Practices (cGMP), US Dietary Supplement GMP and other international food laws and regulations.
Some specific areas of responsibility include determination of product suitability, formula analysis, research of International, Federal, State and internal regulatory requirements, and the use of independent judgement during customer and cross functional team interactions.
The Regulatory Compliance Specialist plays a key role on the Solutions Regulatory Team.Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Research and interpretation of vendor data, internal databases, various government regulations and compile information in response to customer inquiries
- Ensure compliance with various government regulations and confirm accuracy of critical information such as CAS#'s, FDA GRAS or Food Additive status, Safety Data Sheets (SDS) and CFR Regulations for Food and Supplement labeling.
- Support management of vendor, manufacturer, and supplier data:
- Understanding of FDA cGMP, FSMA regulations, QA programs, Foreign Supplier Verification Program (FSVP) compliance regulations and compliance of GFSI and NSF standards.
- Review raw materials for compliance with applicable regulations, customer requirements and industry guidelines.
- Maintain uptodate technical and regulatory documentation for raw materials through regular correspondence with global suppliers.
- Organize customer requests, prioritize, and understand urgency of situations.
- Manage workload to provide optimum turnaround times for customer (internal and external) document requests, questionnaires, and process steps of R&D development.
- Review raw material and finished good technical information:
- Examples, FDA Labeling Regulations, GMO regulations, GHS and SDS standards, USP/FCC conformance and standards, raw material applicability to Organic, Vegan, Vegetarian and Non-GMO certifications, HACCP, Food Safety Plans, GFSI requirements.
- Prepare and issue regulatory statements (GMO, BSE, Organic Compliance etc.) to support Marketing and Sales as well as the Quality departments.
- Expand and keep up to date on regulatory expertise.
- Liaise with appropriate regulatory and quality peers in client operations for information exchange and proactive handling of Prinova Solutions safety/regulatory issues; ensure proper understanding in both directions.
- Participate in review of methodologies and best practices with colleagues worldwide.
- All Prinova employees are required to ensure compliance standards with food safety, food defense and food quality. (FDA, ILDPH, FSMA and BRC).
Qualifications:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required Education and/or Experience:
- A Bachelor's degree from an accredited college or university in Food Science, Nutrition, Biology, Chemistry or other science based discipline. A minimum of 12 years of Food Regulatory or Quality experience or similar experience in food or flavor industry
Required Skills/Abilities:
Language Skills
- Ability to verbally communicate with internal and external customers. Strong English writing skills.
Mathematical Skills
- College mathematics required.
Reasoning Ability
- Ability to make educated judgments on correctness, ac
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