QA Document Control Specialist – Pharma GMP

Granules Pharmaceuticals Inc.

Manassas, Northern (VA, KY)

Hybrid

USD 60,000 - 75,000

Full time

12 days ago
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Job summary

Granules Consumer Health, LLC in Manassas, Virginia, seeks a Document Control specialist to maintain GMP-compliant documentation and records. The role supports release of finished product batches and maintenance of training documentation, ensuring alignment with regulatory requirements.

Responsibilities include controlling and archiving batch and change control records, coordinating labeling components, and collaborating with cross-functional teams to meet deliverables.

Qualifications

  • cGMP compliance in pharmaceutical manufacturing.
  • Writing and maintaining cGMP documentation.
  • Analyze data/information and resolve complex issues.
  • Verbal and written communication skills.
  • Work and communicate with cross-functional teams.
  • Prioritize multiple tasks and re-prioritize as needed.

Responsibilities

  • Manage and maintain document control systems and archival records.
  • Route, review, approve, and distribute controlled documents.
  • Track documents with control numbers, logbooks, and status reports.
  • Archive batch records, audit files, vendor files, and change history.
  • Control and issue labeling components and related documents.
  • Provide new hire training on GMP, safety, and pharmacovigilance.

Skills

cGMP
Documentation
Data analysis
Verbal & written communication
Cross-functional collaboration
Prioritization

Education

Science degree

Job description

Granules Consumer Health, LLC in Manassas, Virginia, seeks a Document Control specialist to maintain GMP-compliant documentation and records. The role supports release of finished product batches and maintenance of training documentation, ensuring alignment with regulatory requirements.

Responsibilities include controlling and archiving batch and change control records, coordinating labeling components, and collaborating with cross-functional teams to meet deliverables.

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