Specialist, Quality Compliance

Herbalife • Van Alstyne, TX

1d

About The Position

As Herbalife’s Process Engineer, you’ll play a key role in optimizing manufacturing processes at one of our contract manufacturing sites. You’ll collaborate closely with on-site teams and Herbalife partners to drive efficiency, ensure quality, and make a meaningful impact on the products our customers trust. Support operations in the area of compliance and documentation control. Expertise in the interpretation and implementation of all applicable regulatory requirements and standards (e.g,. 21 CFR Parts 117, 114, 111, MUI Halal, Kosher, Non-GMO, Gluten-free, etc.) Provide Food, Dietary Supplement and Cosmetic (including OTC) label guidance through collaboration, cross functionally, with Regulatory Affairs, Legal, Marketing, Product Science and Product Development. Conduct QA review for all global product labels to verify compliance of the information on the labels to regulatory requirements, including product name, weight statement, ingredient statement, allergen declaration, and nutrition/supplement facts. Ensure there is detailed documented support for product claims. Review various change controls using Agile system including product specifications as related to label claims. Assist in support of any certification programs. Conducts ad-hoc allergen reviews for manufacturing facilities and assists Food Safety Teams to ensure appropriate allergen preventive controls are implemented. Respond to any product investigations. Perform additional duties as assigned. Ensure company procedures are aligned with cGMP, and performing manufacturer quality audits, and investigations. Ensure all nonconformance reports (QIRs, NMRs, MRRs, PEs, NCRs) are appropriately investigated and closed. Ensure the CAPA program is appropriately managed Prepare and provide updates to senior leadership Train personnel on compliance-related topics and procedures as needed Write and revise compliance-related procedures and forms (e.g., SOPs, forms, food safety plans) Maintain all applicable facility registrations Lead all aspects of NSF certification program Lead and coordinate audit prep and audit response activities Run the internal audit programs Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner Participate in the Contract Manufacturer support program by handling audits, new product startups, investigations, corrective and preventive actions (CAPAs), communication and other issues as they arise.

Requirements

• 5 years' experience in quality assurance and compliance in Food or Dietary Supplement industry
• Preferred 3+ years' experience in food regulatory and label compliance
• Working knowledge of GMPs, FDA regulations and documentation procedures
• Understanding of the cGMP manufacturing environment and basic production operation
• he ability to effectively communicate both verbally and in writing with demonstrated influence management
• Comfortable in small group and large group settings.
• Must be detail oriented, take initiative to address tasks independently and be able to function in a fast- paced environment to complete time critical projects or tasks.
• Strong project management skills
• Ability to develop positive relationships and work in a cross-functional team.
• Compliance auditing experience and training skills
• cGMP proficiency
• Proficiency in Microsoft Office applications, including Word and PowerPoint
• Bachelor's Degree in Food Science, Nutrition, Chemistry or related

Nice To Haves

• Preferred 3+ years' experience in food regulatory and label compliance

Responsibilities

• Support operations in the area of compliance and documentation control.
• Expertise in the interpretation and implementation of all applicable regulatory requirements and standards (e.g,. 21 CFR Parts 117, 114, 111, MUI Halal, Kosher, Non-GMO, Gluten-free, etc.)
• Provide Food, Dietary Supplement and Cosmetic (including OTC) label guidance through collaboration, cross functionally, with Regulatory Affairs, Legal, Marketing, Product Science and Product Development.
• Conduct QA review for all global product labels to verify compliance of the information on the labels to regulatory requirements, including product name, weight statement, ingredient statement, allergen declaration, and nutrition/supplement facts.
• Ensure there is detailed documented support for product claims.
• Review various change controls using Agile system including product specifications as related to label claims.
• Assist in support of any certification programs.
• Conducts ad-hoc allergen reviews for manufacturing facilities and assists Food Safety Teams to ensure appropriate allergen preventive controls are implemented.
• Respond to any product investigations.
• Perform additional duties as assigned.
• Ensure company procedures are aligned with cGMP, and performing manufacturer quality audits, and investigations.
• Ensure all nonconformance reports (QIRs, NMRs, MRRs, PEs, NCRs) are appropriately investigated and closed.
• Ensure the CAPA program is appropriately managed
• Prepare and provide updates to senior leadership
• Train personnel on compliance-related topics and procedures as needed
• Write and revise compliance-related procedures and forms (e.g., SOPs, forms, food safety plans)
• Maintain all applicable facility registrations
• Lead all aspects of NSF certification program
• Lead and coordinate audit prep and audit response activities
• Run the internal audit programs
• Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner
• Participate in the Contract Manufacturer support program by handling audits, new product startups, investigations, corrective and preventive actions (CAPAs), communication and other issues as they arise.

Benefits

• Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off.
• Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP).
• Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance.
• Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees