Job Title: Document Controller (Hybrid – GMP Manufacturing Support)
Location: Parsippany, NJ (Hybrid: 4 days onsite, 1 day remote)
Employment Type: Contract
Schedule Flexibility: Must be available for early start times to support manufacturing shifts

Position Overview:
We are seeking a skilled Document Controller to support GMP manufacturing operations by managing the full lifecycle of GxP and non-GxP documentation. The ideal candidate will have hands-on experience with electronic document management systems (EDMS), particularly Veeva Vault, and be proficient in executing document control workflows from initiation to archival.
This role is essential for maintaining documentation accuracy, regulatory compliance, and supporting cross-functional teams in a fast-paced, regulated manufacturing environment.

Key Responsibilities:

• Generate, issue, and track GMP-controlled documents (e.g., batch records, logbooks, worksheets, SOPs, forms) in both hard copy and digital formats.
  

• Initiate and manage document workflows within Veeva Vault (or other EDMS), including routing for review, approval, and periodic review.
  

• Ensure formatting standards and metadata accuracy throughout the document lifecycle.
  

• Collaborate with authors, reviewers, and approvers to ensure timely and compliant documentation processes.
  

• Digitize and archive hardcopy records per site procedures and regulatory requirements.
  

• Monitor and maintain periodic review schedules for controlled documents.
  

• Support the migration of documents from Qumas to Veeva, ensuring metadata integrity and version control.
  

• Partner with manufacturing, quality, validation, and training teams to streamline documentation practices.
  

• Support document formatting, revision, and change control in alignment with GMP and internal SOPs.
  

• Maintain document retention and availability for audits and inspections.

Required Qualifications:

• Direct, hands-on experience in document control within a regulated (GMP/GxP) manufacturing environment.
  

• Proficiency with EDMS platforms, especially Veeva Vault.
  

• Demonstrated ability to manage full document workflows, including initiation, review, approval, and periodic review processes.
  

• Strong attention to detail and understanding of documentation compliance standards.

Preferred Qualifications:

• Experience with additional EDMS platforms (e.g., Qumas, Documentum).
  

• Background in life sciences, pharmaceuticals, or biotechnology.
  

• Familiarity with documentation types beyond regulatory submissions, such as validation protocols, controlled forms, and annual product reviews (APRs).
  

• Experience supporting documentation needs in active plant operations.

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