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Specialist, Document
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OverviewTHE ROLE:The Document Specialist, Technical Services will primarily be responsible for maintaining and approving information in Master Manufacturing Records (MMRs), Formula Site Bill of Materials (BOMs), Agile and Oracle Manufacturing Databases. They will ensure department reference documents are current and generate timely reports. The role is to serve as the documentation technical lead by interfacing with various depts such as Operations, Quality, Sourcing, Engineering, Agile and Project Management teams to collaborate on continuous improvement initiatives. In this function, the Document Specialist, Technical Services will manage meetings and projects to provide updates, timelines, identification and implementation of initiatives that strengthen quality. The Document Specialist provides an important function in providing final approvals to MMRs on behalf of the department, tracking status of manufacturing activities and collaborating with cross functional group to ensure manufacturing batch records encompass all compliance and process requirements.HOW YOU WOULD CONTRIBUTE: Prepare and provide departmental approval for Master Manufacturing Records (MMRs) for Food and Dietary Supplement products based on information in Agile, which involves routing to necessary parties (i.e. other depts. and manufacturers) to obtain consensus and approvals. Manage Formula, SKU and Raw Material information and master files contained in Agile/Oracle applications based on inputs from Engineers to ensure information is current and readily available and reflective of current Manufacturing Operations Ensure documentation compliance to cGMP, CFR and other relevant regulations for Master Manufacturing Records (MMRs) Develop and implement continuous improvement initiatives to strengthen documentation practices, streamline information from Agile to Oracle that have plant wide impact through quality improvements, cost savings, regulatory, production, and/or MBO research projects. Identify incoming project requests from the Operations group and collaborate with Engineers/Scientist to develop project timelines. Analyze and interpret production volume process/data (e.g., plant capacity, annual production volume, production processes) and provide recommendations to Process Engineers to support manufacturing optimization initiatives. Create complex and detailed reports (e.g. Global Ops slides, Quarterly reports, etc.) using various software (e.g. Agile, Business Intelligence, etc.) to export/extract data, and consistently distribute reports to relevant parties on a timely basis. Supports documentation activities (i.e. creation of manufacturing batch records) for sister plants: monitor production schedules and follows-up to help prevent and/or address delays, make corrections, gather necessary approvals, close items, and provides real-time status updates Prepares / edits department documents (e.g., flow charts, Standard Operating Procedure(s) (SOPs), presentations, Work Instructions, training materials, etc.) to ensure clarity and consistency in internal processes Perform project management activities to coordinate Tech Ops resources to ensure timelines are met and monitor completion of tasks. Performs additional duties as assignedWHAT'S SPECIAL ABOUT THE TEAM: • The Technical Services team is comprised of members with a diverse background experience that ensures each teammate gains a holistic understanding of the development process through commercialization.SUPERVISORY RESPONSIBILITIES: • NoneQualificationsSKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:Minimum is 5 years of cGMP experience with LIMS, Agile, Oracle and/or other Product Lifecycle Management computer software systems in a laboratory, Research & Development, Manufacturing, or Quality Control environment, preferably within the food industry. Bachelor's degree in science, nutrition, information services, or related field from an accredited college / university or applicable relevant experience. Good working knowledge of performance testing, scale up to production, manufacturing limitations, stability testing, raw ingredient evaluation, cost analysis and packaging compatibility Must have strong problem solving, interpersonal, teamwork, project management and communication skills (oral & written) Ability to multi-task and solve problems, while maintaining a clear sense of priorities and focus to drive decisions. Understand basic global regulatory requirements, including EU, CAN, APAC/CH, MX, SAM/CAM General knowledge of Good Manufacturing Practices (GMPs) Ability to work with pilot scale equipment. Bachelor's degree in science, nutrition, information services, or related field from an accredited college / university or applicable relevant experience.US Benefits StatementHerbalife 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.
