Regulatory Affairs and Quality Assurance Specialist

2 months ago


merrillville, United States Albanese Confectionery Group, Inc Full time

UNDERSTANDING

The Regulatory Affairs and Quality Assurance Specialist plays a critical role, ensuring in-market regulatory compliance of new and existing products and supports the Quality Management System. An experienced regulatory or quality professional, this person has a strong understanding of applicable regulations, guidance and industry best practice pertaining to food and/or dietary supplement products.

This person will work independently with a high level of responsibility. In addition to label content management, they will take ownership of quality functions and successfully deliver smaller projects and specific regulatory and quality elements within larger projects.


CORE VALUES

Our 5 Core Values are more than just words, they’re a way of life. We know that companies with a strong culture & a higher purpose perform better in the long run.

  • Own It
  • Love People
  • Act for the Greater Good
  • Find a Way
  • Hustle and Refuse to Settle


RESPONSIBILITIES

  • Reviews, maintains, and creates label records for food and dietary supplement products by interpreting and applying applicable FDA regulations and guidance.
  • Compiles and interprets substantiation documentation for accurate and compliant labeling.
  • As directed, 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.
  • Supports review of product ideations, raw material assessments, formulation assessment, new claims, labels, advertising materials, third party products and related brand activities.
  • Performs evaluations to substantiate compliant labeling: formula, percent daily values, nutritional claim support, structure/function claims.
  • Creates formal assessment documents for customer records.
  • Develop and maintain accurate and compliant label content for dietary supplements and foods, as applicable.
  • Create and/or revise Standard Operating Procedures (SOPs) to improve the quality management system.
  • Participate in process qualifications. Create supporting documents.
  • Identify guidance documents, regulations, and international standards to provide interpretive assistance.
  • Perform CAPA investigations, implement corrective actions, and perform effectiveness checks.
  • Coordinate and maintain sampling and testing procedures. Facilitate lot release testing.
  • Review and maintain statistical sampling plans for quality inspections.
  • 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.
  • Support and improve Quality Systems by providing ongoing education on regulatory compliance.
  • Performs other duties as assigned.


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 REQUIRED

  • 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.

EDUCATION

  • Functional experience: 3 to 5 years of relevant prior business experience preferred. 1 to 2 years of experience in regulatory affairs or quality preferred.
  • Knowledge of international regulations (e.g. Health Canada, EU) a plus.



  • merrillville, United States Albanese Confectionery Group, Inc Full time

    UNDERSTANDINGThe Regulatory Affairs and Quality Assurance Specialist plays a critical role, ensuring in-market regulatory compliance of new and existing products and supports the Quality Management System. An experienced regulatory or quality professional, this person has a strong understanding of applicable regulations, guidance and industry best practice...


  • Merrillville, United States Albanese Confectionery Group, Inc Full time

    UNDERSTANDINGThe Regulatory Affairs and Quality Assurance Specialist plays a critical role, ensuring in-market regulatory compliance of new and existing products and supports the Quality Management System. An experienced regulatory or quality professional, this person has a strong understanding of applicable regulations, guidance and industry best practice...


  • Merrillville, Indiana, United States Right at Home Merrillville, IN Full time

    Job OverviewWe are seeking a highly organized and detail-oriented Caregiver Scheduler and Quality Assurance Specialist to join our team at Right at Home Merrillville, IN.

  • Nurse Practitioner

    4 days ago


    Merrillville, Indiana, United States Lincolnshire Health and Rehabilitation Center Full time

    Lincolnshire Health and Rehabilitation Center offers a competitive salary of $70,000 per year.Job OverviewWe are seeking a skilled Nurse Practitioner - Patient Care Specialist to join our team at Lincolnshire Health and Rehabilitation Center in Merrillville, Indiana.About the RoleThis is an exciting opportunity for a qualified Nurse Practitioner to provide...


  • Merrillville, Indiana, United States Methodist Hospitals Full time

    About the Role:As a Medical Office Administrative Specialist at Methodist Hospitals, you will play a vital role in providing seamless patient experiences. Your strong organizational skills and attention to detail will ensure efficient appointment coordination and administrative tasks.Responsibilities:Coordinate patient check-in and check-out processes,...

  • Froster Specialist

    2 days ago


    Merrillville, Indiana, United States Nothing Bundt Cakes Full time

    Career Opportunity: Froster SpecialistWe are seeking a highly skilled and detail-oriented Froster Specialist to join our team at Nothing Bundt Cakes. As a Froster Specialist, you will be responsible for creating cakes of the highest quality for our guests while maintaining superior service standards.The ideal candidate will have excellent communication...


  • Merrillville, United States Panduit Full time

    At Panduit, Our People Make the Difference. We're looking for individuals who share our passion for innovation, diversity and inclusion, and sustainability. What You Will Do We are excited to be opening our new distribution facility in Merrillville, IN using state-of-the-art technology while minimizing our carbon footprint. Our 400,000 square foot facility...


  • Merrillville, Indiana, United States Sam's Club Full time

    About the JobWe are looking for a talented Café Associate Specialist to join our team at Sam's Club. As a Café Associate Specialist, you will be responsible for ensuring high-quality products are fresh, ready, and available in the café.You will maintain a clean, sanitized, and member-ready area, prepare and serve ready-to-eat food, and pack ready-to-sell...


  • Merrillville, United States Chili's Grill & Bar Full time

    QA/Expeditor - Southlake Chili's 2425 Southlake Mall Merrillville, IN 46410 Role Overview Our Quality Assurance Specialists ensure each Guest receives perfectly prepared, high-quality food. They provide dependable, fast service that is absolutely Chili's! If you take pride in great team work, then we want to hear from you! Fast hiring process Flexible...


  • Merrillville, Indiana, United States Red Nar Mediterranean Grill Full time

    Job DescriptionIn a dynamic kitchen environment at Red Nar Mediterranean Grill, we are seeking a highly skilled and motivated Master Kitchen Specialist to join our team.We offer a competitive salary of $40,000 - $60,000 per year, depending on experience. As a key member of our culinary team, you will be responsible for:Ensuring the highest standards of food...


  • Merrillville, Indiana, United States ImageFIRST Healthcare Laundry Specialists Full time

    About Us:Founded in 1967, ImageFIRST Healthcare Laundry Specialists is the industry leader in infection prevention and patient satisfaction. We strive to provide exceptional service to our customers and create a positive work environment for our associates.The Role:We are seeking a motivated and customer-focused individual to join our team as a Route Sales...


  • Merrillville, Indiana, United States KA Recruiting Inc. Full time

    **Job Summary:**KA Recruiting Inc. is seeking a highly skilled Microbiology Technologist to join our team in the Northwestern Indiana area. This permanent, full-time opportunity offers a competitive salary, full benefits, and a sign-on bonus or relocation assistance.**Key Responsibilities:**Perform clinical laboratory procedures, examinations, and tests...


  • Merrillville, United States Meca Engineering Corporation Full time

    Job DescriptionJob DescriptionJob Overview:As an Electrical Engineer at MECA Engineering Corporation, you will play a critical role in the coordination and execution of the MEP (Mechanical, Electrical, and Plumbing) and fire protection components of our projects. Working from the pre-construction stage through to post-construction, you will ensure that all...


  • Merrillville, Indiana, United States BayMark Health Services Full time

    Exciting PRN Physician Role in Merrillville, INWe are seeking a part-time physician to join our team at MedMark Treatment Centers in Merrillville, IN. As an Addiction Medicine Specialist, you will play a critical role in helping patients achieve long-term recovery and improve their quality of life.About the RoleAdmit patients for methadone and buprenorphine...


  • Merrillville, Indiana, United States BrightSpring Health Services Full time

    Job OverviewWe are seeking a highly skilled Payroll and Benefits Expert to join our team at ResCare Community Living. As a Payroll and Benefits Expert, you will be responsible for performing complex tasks related to payroll and benefits administration, including calculating wages, deductions, and taxes, and administering benefits programs.Key...


  • Merrillville, Indiana, United States i4 Search Group Full time

    Job Title: Dialysis Healthcare SpecialistWe are seeking an experienced and dedicated Registered Nurse (RN) to join our hemodialysis healthcare team in providing safe and effective dialysis therapy for patients.About the Role:As a Dialysis Healthcare Specialist, you will function as part of our multidisciplinary team in delivering high-quality patient...


  • Merrillville, Indiana, United States AccessAbilities Full time

    Unlock a Rewarding Career in Autism TherapyWe are seeking highly motivated and compassionate individuals to join our team as Autism Therapy Specialists. As an integral part of our multidisciplinary team, you will play a crucial role in providing high-quality Applied Behavior Analysis (ABA) therapy to children with autism.About the RoleIn this challenging yet...


  • Merrillville, Indiana, United States Tradebe Full time

    Job Title: Master Data Specialist - Environmental ServicesCompany: Tradebe Environmental ServicesLocation: Merrillville, INTradebe Environmental Services is a global leader in environmental services with a strong presence in Merrillville, IN. We are seeking a highly skilled Master Data Specialist to join our team.Key Responsibilities:Create new customer...


  • Merrillville, Indiana, United States Spring Mill Health Campus Full time

    About the RoleWe are seeking a highly skilled Nursing Care Specialist to join our team at Spring Mill Health Campus. As a key member of our nursing staff, you will be responsible for delivering high-quality care to our residents while maintaining a safe and healthy environment.Job ResponsibilitiesLead a team of direct care providers to ensure effective...


  • Merrillville, Indiana, United States BayMark Health Services Full time

    We are seeking a part-time physician to join our team at MedMark Treatment Centers in Merrillville, IN. As an Addiction Medicine Specialist, you will play a vital role in helping patients achieve long-term recovery and improve their quality of life.**Job Summary:**The primary function of this position is to admit patients for methadone and buprenorphine...