Quality Document Control Specialist

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 (employee and depend.)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
PTO / Vacation

Job summary

Actalent is seeking a meticulous Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. You will maintain lifecycle, ensure current, approved documents, and support audits.

Strong attention to detail and proficiency with Word/Excel, plus familiarity with ISO/FDA requirements, are essential for this contract-to-hire role. Be prepared to handle document control metrics, training, and confidential information while collaborating with Quality

Qualifications

  • High school diploma or GED required; some college preferred.
  • 13 years of experience in document control or a regulated environment.
  • Proficiency in document control, change control, and quality assurance.
  • Experience with device history records and audit processes.
  • Strong understanding of document control, change management, and records retention.
  • Working knowledge of ISO and FDA quality system requirements 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
Device history records
Audit processes
ISO quality system requirements
FDA quality system requirements
High attention to detail
Multitasking
Word processing

Education

High school diploma or GED
Some college preferred

Tools

Microsoft Word
Microsoft Excel
Outlook
Document management systems

Job description

Actalent is seeking a meticulous Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. You will maintain lifecycle, ensure current, approved documents, and support audits.

Strong attention to detail and proficiency with Word/Excel, plus familiarity with ISO/FDA requirements, are essential for this contract-to-hire role. Be prepared to handle document control metrics, training, and confidential information while collaborating with Quality

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