Document Control Specialist

Nephron Pharmaceuticals Corporation; Columbia, Northern (SC, KY); Hybrid; USD 42,000 - 64,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a Document Control Specialist to learn and perform document control functions, support the Quality Management System, and create and maintain SOPs and change controls in accordance with cGMP.

You will use LabVantage, SharePoint, and DOT Compliance software, prepare batch records, maintain archives, and manage document distribution while coordinating with cross‑functional teams. Some overtime and weekend work may be required.

Qualifications

• Minimum of 1 year in the pharmaceutical industry preferred.
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.
• Knowledge of cGMP and FDA regulations.
• Proficient in Microsoft Word and Excel; Adobe Acrobat advanced features.

Responsibilities

• Route new and revised controlled documents using DOT Compliance software systems.
• Assist with document accuracy including formatting headers/footers, spelling, grammar, and numbering.
• Manage and maintain document archive process.
• Maintain original and working copy binders with latest revisions.
• Maintain LIVE DOCs with current revisions.
• Update Master Distribution List and Table of Contents with current document data.
• Perform daily and quarterly audits to ensure correct document versions are used.
• Assist with batch record preparation: review schedule, generate batch records, create batch IDs, respond to requests.

Skills

cGMP

FDA regulations

Document control

Microsoft Word

Microsoft Excel

Adobe Acrobat

Time management

Communication skills

Cross-functional collaboration

Education

1 year in pharmaceutical industry

Tools

LabVantage

SharePoint

DOT Compliance software

Job description

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 and 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.
  • 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.

Supplemental Functions:

• Copying, filing, and scanning of documents.
• Performs other similar duties as required.

Requirements

Knowledge & Skills:

• 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.

Education/Experience:

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

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.