Audit-Ready Document Control Lead

Actalent

Ventura (CA)

On-site

USD 36,000 - 41,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental & vision
401(k) Retirement Plan
Life Insurance
Disability insurance
Health Savings Account (HSA)
Transportation benefits
Paid Time Off (PTO)

Job summary

Actalent is seeking a Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. The role focuses on accuracy, timely approvals, and adherence to ISO/FDA standards, supporting audit readiness and cross-functional teams.

The position handles full document lifecycle management, version control, and archival, while ensuring current, approved documents are accessible at use points.

Qualifications

  • High school diploma or GED required.
  • Some college preferred.

Responsibilities

  • Manage the full document lifecycle: creation, review, approval, revision, distribution, and archival.
  • Maintain document formatting, numbering, version control, and naming standards.
  • Ensure only current, approved documents are available at points of use.
  • Coordinate document change requests and track approval workflows.
  • Track revision histories, effective dates, and document status.
  • Remove obsolete documents and maintain archives per retention requirements.
  • Maintain traceability between documents, records, and change controls.
  • Manage quality records such as training records, batch records, DHRs, and DMRs as applicable.
  • Support internal and external audits by retrieving and organizing documentation.
  • Monitor document control metrics and support management review.
  • Provide guidance and training to document authors and employees on document control processes.
  • Maintain confidentiality and data integrity of sensitive information.
  • Provide administrative support to Quality leadership as needed.

Skills

Document control
Change control
Quality assurance
Audit readiness
Attention to detail
MS Word
Excel
Outlook
Document management systems
Written & verbal communication

Education

High school diploma or GED

Tools

Microsoft Word
Microsoft Excel
Outlook

Job description

Actalent is seeking a Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. The role focuses on accuracy, timely approvals, and adherence to ISO/FDA standards, supporting audit readiness and cross-functional teams.

The position handles full document lifecycle management, version control, and archival, while ensuring current, approved documents are accessible at use points.

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