Quality Regulatory Specialist

  • Permanent
  • Anywhere

Website creative werks

creative werks

Company : creative werks

Country: United States

Location : Elk Grove Village, Illinois

Post: Wed, 01 Feb 2023 20:39:25 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

The Quality Regulatory Specialist is responsible for the support of both internal and external customers as it pertains to maintenance of regulatorily required documentation and specifications. The role works cross functionally to help manage and prioritize customer needs and requests including specifications, questionnaires, labeling, identity preserved statuses. The QRS also is responsible for identifying opportunities to standardize and streamline processes, reduce unnecessary redundancy, and continuously improve management food safety, quality, and regulatory compliance systems to create value for CW and its customers.
Essential Duties and Responsibilities
Create, maintain, and update the company’s Food Safety Plans, Food Defense Plans, and Food Quality Plans, keeping current with all new or changing processes or products.
Ensure documentation of all regulatory required records and related files are complete, accurate, and uploaded into SharePoint.
Review and manage all raw material specifications for current and new products.
Create, route for approvals, and publish internal co-pack product specifications.
Management of Food Safety and Quality Item setups in ERP (Syteline).
Creation and updates to in-process documentation QMS software (Qwerks).
Participate as team member, supporting internal and external audits.
Proof and approve primary packaging label artwork for accurate information prior to first production.
Complete finished product label audits against ingredient specifications and label approvals.
Administrate the Identity Preserved status program (kosher, organic, NGP, gluten free, etc.).
Monitor company policies and procedures for compliance with FDA regulations, and identity preserved statuses (kosher, organic, NGP, gluten free, etc.).
Provide requested documentation via email, customer portals, and through uploading into 3rd party systems such as TraceGains.
Assist in creation, updating, and implementation of Standard Operating Procedures and Standard Work documents.
Calculate checkweigher control limit weights based on declared labeling and demonstrated equipment capabilities to ensure compliance with NIST net content requirements.
Model the Company’s values of passion, resilience, performance, creativity, accuracy, balance, collaboration, flexibility, and innovation.
Performs other duties as assigned by Management.
Knowledge, Skills and Abilities
Working knowledge of labeling laws, ingredient statement builds, allergen issues, and government regulations (CFR 21, NIST HB 133, NOP, etc.)
Demonstrated competency at creating food safety and food defense plans, and utilization of other risk assessment tools.
Competency with quality/food safety programs including HACCP, SSOP, Integrated Pest Management, FDA cGMP
Versed in potential hazards for foods and processes, and appropriate mitigation techniques.
Competent with Microsoft Office (i.e. intermediate Word formatting, Excel pivot tables, Visio, and SharePoint) is required.
Familiarity and adaptability to auxiliary programs such as ERP.
Collaborative approach: able to work cross-functionally and with external resources.
Education and Experience
Bachelor of Science (BS) degree in life or physical sciences, Food Science, Engineering, or related field
3-5 years’ experience in related discipline
Certified in HACCP and/or PCQI required
Certification in FDQI preferred

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