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.
SUPERVISORY RESPONSIBILITIES:
• QA Compliance Specialist
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
• 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
Education
• Bachelor's Degree in Food Science, Nutrition, Chemistry or related
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