Document Control Lead - Compliance & QA Excellence

Nephron Pharmaceuticals Corporation

West Columbia (SC)

On-site

USD 90,000 - 130,000

Full time

14 hours ago
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Job summary

Nephron Pharmaceuticals Corporation in West Columbia, SC is seeking a Document Control Manager to lead daily control operations ensuring compliant, current documentation across the organization. You will manage the team, oversee electronic and paper records, and ensure adherence to cGMP and FDA requirements.

The role emphasizes ALCOA+ data integrity, batch record lifecycle management, and collaboration with Quality Assurance, Manufacturing, and PD teams to maintain audit-ready documentation and

Qualifications

  • Bachelor's degree in Life Sciences or related field, preferred.
  • 3–5 years of document control/QA in a regulated environment.
  • Experience with cGMP, FDA regulations, and data integrity.
  • Hands-on with TrackWise or similar DMS and batch-record systems.
  • Supervisory or team-lead experience is a plus.

Responsibilities

  • Oversee document control operations, ensuring accuracy and compliance.
  • Manage electronic and paper document workflows and archival.
  • Maintain version control, audit trails, and access controls.
  • Support regulatory inspections and CAPA/change-control activities.
  • Lead and mentor the Document Control team to meet deadlines.

Skills

Quality Assurance
cGMP
FDA regulations
Data integrity
Document control
Records retention
Batch records
Process Development docs
Team leadership
Microsoft Office
Adobe Acrobat

Education

Bachelor's degree in Life Sciences

Tools

TrackWise
TrackWise Digital
Dot Compliance
Electronic Batch Records

Job description

Nephron Pharmaceuticals Corporation in West Columbia, SC is seeking a Document Control Manager to lead daily control operations ensuring compliant, current documentation across the organization. You will manage the team, oversee electronic and paper records, and ensure adherence to cGMP and FDA requirements.

The role emphasizes ALCOA+ data integrity, batch record lifecycle management, and collaboration with Quality Assurance, Manufacturing, and PD teams to maintain audit-ready documentation and

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