Document Control and Data Management Specialist

Job Description

Document Control and Data Management Specialist - Forsyth, MO

SUMMARY: 
The Document Control and Data Management Specialist is responsible for processing-controlled documents and records, including Standard Operating Procedures, Forms, Specifications, Batch Records, Result Reports, and other controlled documents that support company operations. Maintains records for quality and production equipment including Equipment Manuals, Maintenance Repair, and Calibration documents. Manages the Deerland Document Control system to ensure the latest revision of documentation is processed and available. Processes spec change and formulation set up and revision requests. Processes product/vendor/customer code requests through current ERP (enterprise resource planning) system and ensure data is entered and updated as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Document Control Responsibilities

• Understand regulatory requirements for operations and document control.
• Maintain the Document Control Software and ensure timely distribution of latest revision and removal of obsolete documentation.
• Maintain hard copies of controlled documents as required.
• Enter data into computerized systems ensuring the accuracy and integrity of such.
• Perform clerical typing duties to generate documents as necessary.
• Maintain training program as it pertains to document changes.
• Manage all customer documents and correspondences including copying, filing, and distributing, as necessary.
• Assist in audits for both customers and agencies.
• Assist with creation of Specifications for raw materials and finished products.
• Assist with creation of SOP’s, Manuals, Forms, and other controlled documents.
• Assist in the issuing, reviewing, and revising of all controlled documents.
• Manage calibrations, manuals, and equipment records through copying, filing, and distributing, as necessary.
• Develop and maintain a working knowledge of practices necessary to maintain compliance with Federal and other regulatory agency requirements, cGMPs (current good manufacturing practices), and other requirements related to Standards and Certifications.
• Scan and file cGMP documentation, as required, including completed batch records and result reports.
• Assist in the issuing, review, and revising process of all documents.
• Manage special projects as assigned by the Director of Quality Assurance.
• Manage Change Control database as it pertains to document creation and revision, including but not limited to (formulations, specifications, certificate of analysis and Standard Operating Procedures).
• Report Metrics as required for responsibilities.

• Approve and or set up formulation, raw material, customer, and supplier in ERP.
• Approve and or creation, obsoletion, and modification of part codes and formulas to support formulation, Certificates of Analysis and specification change requests.
• Update sales pricing, purchase pricing and standard costs as necessary.
• Connect part codes to vendors and customers as required.
• Assist other Quality personnel as required.
• Perform other duties as assigned
• Report metrics as required for responsibilities.

• Basic office equipment: Computer, Fax Machine, Copy Machine, Telephone, Printer, etc. 

• Minimum – High School Diploma
• Preferred - Bachelor’s degree; preferred in Computer Sciences or Business Related field of study

• Minimum 2 years work or educational experience within computer science, information technology, or similar fields. Experience with cGMPs for dietary supplements, Quality Management Systems, and certification standards required.

SPECIFIC SKILLS: 

• Identifies and resolves problems in a timely manner
• Ability to multi-task with attention to detail
• Excellent written and oral communication
• Results driven, strong work ethic
• Adapts to changes in work environment while learning to apply new technologies
• Follows instructions, responds to management direction
• Strong time management
• Ability to work independently
• Working knowledge and experience pertaining to cGMP standards
• Sound working knowledge of IT Systems, practical knowledge of Microsoft office suite software including Excel, Word, and PowerPoint

• Sales, Marketing, Technology, Quality, Manufacturing, Finance

• Customers, Contractors