Specialist, Document (Technical Operations)

Herbalife•Winston-Salem, NC

About The Position

The Documentation Specialist, Technical Operations will primarily be responsible for maintaining and approving information in Master Manufacturing Records (MMRs), Formula Site Bill of Materials (BOMs), WWRDSA database. They will ensure department reference documents are current, and generate timely reports. The role is to serve as the Technical Operations liaison by interfacing with various depts such as Operations, Quality, Sourcing, Engineering, PD&M, Agile and Project Management teams to collaborate on continuous improvement initiatiatives. In this function, the Specialist, Document Technical Operations will manage meetings to provide updates, project timelines and identify upcoming department requirements. The Documentation Specialist, Technical Operations provides an important function in providing final approvals to MMRs on behalf of the department, tracking status of manufacturing activities and assisting Engineers to ensure they have up-to-date information to improve manufacturing processes while ensuring documentation requirements are met.

Requirements

Experience using Agile or other PLM software applications.
Ability to stay focused in a fast-paced environment with changing priorities.
Good written and verbal communication and interpersonal skills
Customer service mindset
Disciplined in planning, tracking and communicating changes.
High attention to detail
Basic knowledge of Microsoft Office (i.e. Outlook, Word and Excel) programs
Familiar with data management and scientific principles / practices as it relates to the Food Industry and Nutrition
Familiar with current Good Manufacturing Practices (cGMP), Good Documentation Practices (CGDP), USP requirements, Food and Drug Administration (FDA), and other regulatory regulations and guidelines
Familiar with SOPs applicable to WWRDSA and related to testing of raw materials or finished products, proper documentation, safe operation of laboratory instruments and equipment, and handling of chemicals and raw materials
Familiarity with general scientific software applications (e.g. LIMS, Genesis, etc.)
Minimum is 5 years of cGMP experience with LIMS, Agile, Genesis, SharePoint, Oracle 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.
May consider candidate with an additional 4 years of relevant work experience in lieu of degree.

Nice To Haves

Prior experience at Herbalife and familiarity with our data systems e.g., Oracle or other Enterprise Resource Planning systems

Responsibilities

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 WWRDSA databases (e.g., WWRDSA portal, SharePoint Libraries, team sites, and network folders) and 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 continuous improvement initiatives to improve documentation practices, streamline information from from Agile to Oracle that have plant wide impact.
Contribute to process improvement intiatives by proactively communicating ideas to P&DM and Tech Ops Team leadership.
Identify incoming project requests from the Operations group and collaborate with Engineers/Scientist to monitor completion of tasks.
Analyze and interpret production volume process/data (e.g., plant capacity, annual production volume, production processes) and provide recommendation to Engineers to support manufacturing optimization initiatives.
Coordinate activities to fulfill Tickets for Tech Ops activities and any other requests supported by change control (cost savings), regulatory, production, and/or MBO research projects.
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 distributes reports to relevant parties on a timely basis.
Supports documentation activities for sister plant (LF, VA, WS): 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. based on feedback from Engineers/Scientists to ensure clarity and consistency in internal processes
Perform project management activities to coordinate Tech Ops rsources to ensure timelines are met and monitor completion of tasks.
Perform other duties as assigned