Senior Document Control Specialist (QA/Regulatory)

Actalent; Ventura (CA); On-site; USD 36,000 - 41,000; Full time

Job summary

Actalent is seeking a Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. You will oversee the full lifecycle from creation to archival and ensure compliance with QA and regulatory standards.

Responsibilities include maintaining version control, coordinating change requests, and supporting audits. Strong attention to detail and experience in regulated environments are essential for success in this role.

Qualifications

• High school diploma or GED required; some college preferred.
• 13 years of experience in document control or a regulated environment.
• 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

ISO/FDA knowledge

Attention to detail

Time management

Written communication

Software learnability

Education

High school diploma or GED

Tools

Microsoft Word

Excel

Outlook

Document management systems

Job description

Actalent is seeking a Document Control Specialist to manage controlled documents within a regulated quality system in Ventura, CA. You will oversee the full lifecycle from creation to archival and ensure compliance with QA and regulatory standards.

Responsibilities include maintaining version control, coordinating change requests, and supporting audits. Strong attention to detail and experience in regulated environments are essential for success in this role.