Quality Assurance and Regulatory Affairs Manager

6 days ago

Merrillville, Indiana, United States Albanese Candy Full time
About the Role

The Regulatory Affairs and Quality Assurance Specialist plays a critical role in ensuring in-market regulatory compliance of new and existing products and supports the Quality Management System at Albanese Candy.

Key Responsibilities
  • Regulatory Compliance: Reviews, maintains, and creates label records for food and dietary supplement products by interpreting and applying applicable FDA regulations and guidance.
  • Label Content Management: Compiles and interprets substantiation documentation for accurate and compliant labeling.
  • Project Ownership: Takes ownership of, and delivers successfully smaller projects and specific regulatory elements within larger projects such as innovation, implementation of new regulations, portfolio assessment and change control.
  • Quality Support: Supports review of product ideations, raw material assessments, formulation assessment, new claims, labels, advertising materials, third party products and related brand activities.
  • Evaluations and Assessments: Performs evaluations to substantiate compliant labeling: formula, percent daily values, nutritional claim support, structure/function claims.
  • Documentation and SOPs: Creates formal assessment documents for customer records and develops and maintains accurate and compliant label content for dietary supplements and foods, as applicable.
  • Process Improvements: Creates and/or revises Standard Operating Procedures (SOPs) to improve the quality management system and participates in process qualifications.
  • Regulatory Research: Identifies guidance documents, regulations, and international standards to provide interpretive assistance.
  • CAPA Investigations: Performs CAPA investigations, implements corrective actions, and performs effectiveness checks.
  • Sampling and Testing: Coordinates and maintains sampling and testing procedures and facilitates lot release testing.
  • Quality Systems: Reviews and maintains statistical sampling plans for quality inspections and demonstrates a high level of understanding of applicable regulations and implements process improvements when required to ensure quality systems are maintained at a high level.
  • Education and Training: Supports and improves Quality Systems by providing ongoing education on regulatory compliance.
Working Relationship
  • Reports to the Quality Assurance Manager.
  • Communicates regularly and has a strong relationship with team members in multiple departments.
  • Communicates and meets periodically with other departmental leaders.
Qualifications
  • Thorough understanding of FDA labeling, 21 CFR Part 111, and 21 CFR Part 117 compliance requirements.
  • Good judgement, decisiveness, and strong interpersonal skills.
  • Strong written and verbal communication skills.
  • A self-starter with willingness to learn and develop new processes or procedures.
  • Demonstrates strong teamwork, collaboration, attention to detail, analytical skills, and organization.
  • Previous exposure to and application of regulations pertaining to food and/or dietary supplement manufacturing and labeling.
  • Basic computer skills, including Microsoft Outlook, Excel, Word, and PowerPoint.
  • Capable of managing tasks while rapidly adapting to changing priorities.
  • Able to work independently with minimal supervision.

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