Document Control Specialist

NEPHRON SC, LLC • West Columbia, SC

10d • Onsite

About The Position

The Document Control Specialist will learn and perform Document Control functions, providing support for the Quality Management System. This role involves creating and maintaining standard operating procedures, change control records, and documentation in accordance with cGMP, while assisting in all aspects of the document control process. The specialist will utilize systems such as Laboratory Information Management System (LabVantage), SharePoint, and DOT Compliance software. Responsibilities include preparing and verifying electronic and paper batch records, copying, filing, scanning, and employing organization and time management techniques using Microsoft Outlook. The role also requires flexibility to work overtime and weekends as needed, and to assist with additional work duties as required.

Requirements

• Technical background preferred, with knowledge of cGMP, and FDA regulations.
• Strong understanding of document control procedures, standards, and best practices
• Competent in Microsoft Word and Excel
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows
• Familiar with document management software.
• Effective time management skills including prioritizing and scheduling.
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Familiar with relevant industry regulations and compliance standards.
• Discretion in handling sensitive and confidential information.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.
• Minimum of 1 year in the pharmaceutical industry preferred.
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.

Nice To Haves

• Technical background preferred
• Minimum of 1 year in the pharmaceutical industry preferred
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred

Responsibilities

• 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 LabVantage.
• Respond promptly to 8 – 20 request per day for emails and DOT Compliance.
• Respond promptly to email request including but not limited to: Logbook issuance and return process, Regulatory request, audit request, re-issuance, permissions, etc.
• Respond promptly to DOT Compliance request: Obsolete, grant permissions, implementation, etc.
• Copying, filing, and scanning of documents.
• Performs other similar duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed