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Document Control Administrator

Company: International Vitamin Corporation
Location: Greenville
Posted on: July 29, 2022

Job Description:

Overview:
The Document Control Administrator is responsible for maintaining standard operating procedures (SOPs) /controlled documents systems at the IVC -Anderson (AND), Dairy Drive (DDR / WDD) and Woodruff Road (WOD), SC Facilities in accordance with division, corporate and regulatory requirements. This position is responsible for participating in regulatory and customer (internal / external audits). The Document Control Administrator is also responsible for the development and maintenance of batch records and the batch record storage system at the IVC Facilities noted above. This position is responsible for managing Quality Systems office supplies orders and assisting the Sr. Manager, Quality Systems as needed.

Responsibilities:
STRATEGIC--- Develops and maintains the company's SOP systems in accordance with corporate and regulatory requirements; Reviews, edits, and writes standard operating procedures (SOPs) --- Develops and prepares SOPs using word processing, desktop publishing, and graphic arts; Assist in the coordination of the distribution, signature receipts, filing and archiving of new and revised SOPs--- Performs periodic audits of the SOPs for the purpose of identifying areas of deficiencies; Ensures deficiencies are addressed; Assists in regulatory and customer (internal / external) audits--- Develops and maintains the procedure for the proper maintenance of batch records for lots of codes produced and packaged at IVC - Woodruff Road (WOD), Anderson (AND) and Dairy Drive (DDR)--- Reviews and preserves all batch record documentation; Creates, updates, and maintains the batch record retrieval program--- Maintains a system for filing and archiving of company batch records at AND, WOD and DDR.--- Scans batch records associated with production, packaging and release of product to the Company's applicable Intranet websiteTACTICAL--- Administers the review, approval, and revision of procedures, specifications, and forms--- Works with initiators to rewrite, clarify, or reconstruct controlled documents; Ensure technical accuracy and traceability of all documentation--- Maintains a tracking system for all procedures / controlled documents--- Interprets and follows the guidance of frequent policy changes, and assessing the effects of changes on linked systems--- Participates and assists in self audits, internal / external customer and external regulatory Quality Systems audits--- Integrates various sources of information into uniform style and language regulatory compliance--- Assist in developing documentation for instructional, descriptive, reference and/or informational purposes--- Provides procedures / controlled documents to internal and external customers; Assists in maintaining an electronic SOP system for the facilities--- Oversees the annual destruction of Batch Records / Controlled Documents and maintains documentation of destruction--- Files, organizes and stores SG gel mass batch records and Tablet / HSC premix batch records--- Maintains the filing, organization and storage of product batch records--- Provides batch record information to internal and external customers--- Assists in ordering department office supplies--- Any and all duties deemed necessary by the Quality Systems Manager regarding the Quality Systems department - -

Qualifications:
Minimum--- 3+ years document control or regulatory administration experience--- 3+ years Quality experience in a cGMP regulated or similar manufacturing environment - Preferred> 5 years Quality and Document Control experience in a cGMP regulated manufacturing facilityEducation--- High school diploma and three years document control or regulatory administration experience may be substituted for minimum educational requirementsPreferredTwo-year degree in Science, English, Communications or related fieldQualifications--- Proficiency in Microsoft Office Suite (Outlook, MS Excel, MS Word, PowerPoint preferred)--- Knowledge of Internet browser (i.e., Internet Explorer, where scanned batch records reside) --- Knowledge of electronic database (i.e., MasterControl)--- Knowledgeable of cGMP / FDA regulatory requirements--- Exposure to regulatory and customer audits--- Highly organized with strong written and verbal communication skills--- Demonstrated professional communication abilities--- Strong root cause analysis and troubleshooting skills--- Ability to interact with various departments and skill levels in a professional and consistent manner

Keywords: International Vitamin Corporation, Greenville , Document Control Administrator, Other , Greenville, South Carolina

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