Manager, Quality Assurance

Herbalife•Van Alstyne, TX

About The Position

THE ROLE: As Herbalife’s QA Manager, you’ll play a meaningful role in ensuring product quality and compliance at one of our contract manufacturing sites. You’ll collaborate closely with on-site teams and Herbalife partners to uphold the highest standards and make a real impact on the products our customers trust. HOW YOU WOULD CONTRIBUTE: • Lead the operations of Quality Assurance, Quality Compliance and Document Control.• Serve as a subject matter expert 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.)• Lead all aspects of quality documentation related to product batch records, deviations, and change controls.• Quality management of raw materials and components used in production of Herbalife products.• Ensuring facility is a state of GMP compliance with proper temperature, humidity and cleaning log maintenance.• Developing company procedures aligned with cGMP, and performing manufacturer quality audits, and investigations.• Approve deviations and other quality-related documents requiring management review• 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• Coach, train and develop staff• Communicate and/or interact with compliance experts and consultants as required• Perform other related duties as assigned by management. • 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)• Ensure site has appropriately trained PCQIs (Preventive Controls Qualified Individual) for FSMA• Ensure food safety plans are created and maintained for all relevant product types• Ensure review, monitoring and verification activities are performed for all food safety plans • Evaluate changes to facilities, materials, products and equipment for impact on compliance• Maintain all applicable facility registrations• Lead all aspects of NSF certification program• Oversee and coordinate audit prep and audit response activities• Manage the internal audit, allergen control and gluten-free programs• Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner• Monitor and maintain KPI performance• Perform the Quality review of SKUs, Formulas, FSFs, Labels and Deviations as needed.• Perform the QA functions of the stability program including evaluating testing data, assigning shelf-life and signing final reports or forms as needed.• 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

7+ years working for a food, supplement or cosmetic company
5+ years manufacturing operation experience
Expertise of GMPs, FDA regulations and documentation procedures
Lead and manage QA functions and programs
Effectively communicate cross functionally with peers, associates and upper level management
Excellent written and verbal communication skills
Ability to work independently as well as a team.
Coaching and mentoring skills - team development
Compliance auditing experience and training skills
cGMP proficiency
Proficiency in Microsoft Office applications, including Word and PowerPoint

Responsibilities

Lead the operations of Quality Assurance, Quality Compliance and Document Control.
Serve as a subject matter expert 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.)
Lead all aspects of quality documentation related to product batch records, deviations, and change controls.
Quality management of raw materials and components used in production of Herbalife products.
Ensuring facility is a state of GMP compliance with proper temperature, humidity and cleaning log maintenance.
Developing company procedures aligned with cGMP, and performing manufacturer quality audits, and investigations.
Approve deviations and other quality-related documents requiring management review
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
Coach, train and develop staff
Communicate and/or interact with compliance experts and consultants as required
Perform other related duties as assigned by management.
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)
Ensure site has appropriately trained PCQIs (Preventive Controls Qualified Individual) for FSMA
Ensure food safety plans are created and maintained for all relevant product types
Ensure review, monitoring and verification activities are performed for all food safety plans
Evaluate changes to facilities, materials, products and equipment for impact on compliance
Maintain all applicable facility registrations
Lead all aspects of NSF certification program
Oversee and coordinate audit prep and audit response activities
Manage the internal audit, allergen control and gluten-free programs
Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner
Monitor and maintain KPI performance
Perform the Quality review of SKUs, Formulas, FSFs, Labels and Deviations as needed.
Perform the QA functions of the stability program including evaluating testing data, assigning shelf-life and signing final reports or forms as needed.
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.

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