The incumbent performs staff duties within the KDC/One- Lynchburg Document Control Unit (DCU). This position collects, maintains, and distributes all documents necessary to define product configuration and control manufacturing processes that insure conformance to customer requirements. Other duties include:
Independently provides a Document Control review of all formulations and manufacturing directions; this includes ensuring customer requirements are met, checking calculations, and verifying the batch records are consistent with the SAP inventory system
Analyze and revise draft copies of company forms
Edit and proofread documents for grammar, correct spelling, and clarity
Coordinates primary document input to ensure correct output
Reviews current schedule and submits Master Production Records and other related documents to customers as required
Generates, issues, and controls master documents related to Document Control Processes.
Generates, issues, and controls documents that reside on the company’s computers and in hardcopy manuals.
Works with each KDC/One department to ensure training matrices are updated each time a procedure/test method, etc. is approved/revised
Coordinates internet-based information exchange from customers. This includes the downloading, distribution, and communication of data to the appropriate departments
Enter new and update existing records in Trackwise for approved documents as necessary.
Collects and maintains secured files of the latest revision level documentation necessary to define product configuration and control manufacturing processes.
Timely distribution of the latest revision documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
Maintain a log/database of all filed documentation that ensures fast retrieval of current and archived documentation.
Maintain the documentation control system/log
Create review of documents for revision and approval
Makes entries into the company’s production and inventory control system (SAP) of data including but not limited to Material Masters, bills of materials and recipes for Finished Goods and Semi Finished Goods (bulk and labeled bottles).
Creates and maintains SAP documents linked to controlled documents.
Monitors request for set up of Material Masters in SAP. Advising requestors of conflicts, duplication, and missing data.
Establishes and maintains proper naming of Finished and Semi Finished Goods Material Masters and extended materials from other facilities in the KDC/One network
Issues appropriate manufacturing directions to accompany process orders to the compounding department.
Facilitate the download and distribution of customer specifications and supporting documents from portals or email notifications.
Organizes customer documents in the Document Control Public Drive to include archival of obsolete documents
Distribute Technical Documentation to the appropriate people within the facility, and issue change controls accordingly.
Keep customer documentation in the locked file cabinet to protect the customer’s confidentiality
Facilitate the closure of customer-based change controls
Oversee receipt of all standards, follow up with the customer or vendor as appropriate, and work with the KDC/One-Lynchburg team on awareness of what standards have been received and what is still needed in tracking toward First Production along with maintaining Standards Database
Route paperwork for Finished Good Bills of Material as requested by Customer Account Managers to include internal and customer documentation
Other Duties as assigned
Education and Experience:
Two or more years of college or experience in quality
Knowledge, Skills, and Abilities:
Excellent oral and written communication skills
Skill in use of computer, particularly spreadsheet and word processing software
Ability to listen, note key points, and develop documents from notes and outlines
Perform multiple tasks simultaneously and manage time efficiency
A self-starter who can work independently or be a team player.