THE 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 assigned
WHAT’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:
• None
