Document Control Specialist

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 (LabVantage), 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.

Essential Duties

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Responsibilities:

o Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using DOT Compliance software systems. o 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. o Manage and maintain document archive process. o Maintain original and working copy binders to ensure they contain the latest effective revisions. o Maintain LIVE DOCs to ensure they contain the latest effective revisions. o Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date. o Perform daily and quarterly audits to ensure the correct version of effective documents is in binders and used in preparing batch records. o Assist with the preparation and verifying of batch records as demanded by the Production/Packaging

Schedule:

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

Supplemental Functions: Copying, filing, and scanning of documents. Performs other similar duties as required.