Document Control Specialist Job West Columbia area,South Carolina USA,Administrative/Clerical

Ability to learn and perform Document Control functions.
Provide support for the Quality Management System.
Create and maintain standard operating procedures, change control records, and documentation in accordance with cGMP while assisting as needed in any aspect of the document control process.
Utilization of Laboratory Information Management System (Lab Vantage), SharePoint, and DOT Compliance software systems.
Prepare and verify electronic and paper batch records.
Requires copying, filing, and scanning.
Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.
Assists with additional work duties or responsibilities as evident or required.
Flexibility to work overtime and weekends, if required.
Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using DOT Compliance software systems.
Assist with document accuracy including, but not limited to: formatting headers and footers, spelling corrections, appropriate grammar and punctuation, consistent fonts and numbering sequences, etc.
Manage and maintain document archive process.
Maintain original and working copy binders to ensure they contain the latest effective revisions.
Maintain LIVE DOCs to ensure they contain the latest effective revisions.
Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date.
Perform daily and quarterly audits to ensure the correct version of effective documents is in binders and used in preparing batch records.
Assist with the preparation and verifying of batch records as demanded by the Production/Packaging

Schedule:
Review production schedule to determine what needs to be performed.
Perform batch record generation for Nephron and 503B.
Create batch IDs using Lab Vantage.
Email and DOT system Activities
Promptly respond to 8 – 20 request per day for emails and DOT Compliance.
Promptly respond to email request including but not limited to:
Logbook issuance and return process, Regulatory request, audit request, re-issuance, permissions, etc.
Promptly respond to DOT Compliance request:
Obsolete, grant permissions, implementation, etc.

Job Purpose

Ability to learn and perform Document Control functions.
Provide support for the Quality Management System.
Create and maintain standard operating procedures, change control records, and documentation in accordance with cGMP while assisting as needed in any aspect of the document control process.
Utilization of Laboratory Information Management System (Lab Vantage), SharePoint, and DOT Compliance software systems.
Prepare and verify electronic and paper batch records.
Requires copying, filing, and scanning.
Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.
Assists with additional work duties or responsibilities as evident or required.
Flexibility to work overtime and weekends, if required.
Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using DOT Compliance software systems.
Assist with document accuracy including, but not limited to: formatting headers and footers, spelling corrections, appropriate grammar and punctuation, consistent fonts and numbering sequences, etc.
Manage and maintain document archive process.
Maintain original and working copy binders to ensure they contain the latest effective revisions.
Maintain LIVE DOCs to ensure they contain the latest effective revisions.
Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date.
Perform daily and quarterly audits to ensure the correct version of…