Document Controller & CQV Engineer — cGMP/EDMS Pro

Verista; Olde West Chester (OH); On-site; USD 59,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental & Vision insurances

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Verista in West Chester, Ohio is seeking an experienced Document Controller to support document management in a regulated pharmaceutical manufacturing environment. You will manage creation, routing, review, approval, and archival of controlled documents in the EDMS, and ensure GDP/cGMP compliance.

The role requires hands-on Veeva experience, knowledge of cGMP/GDP, meticulous attention to detail, and ability to coordinate with Quality, Engineering, Validation, and Manufacturing teams onsite.

Qualifications

• Previous Document Control experience within pharmaceutical or other highly regulated life sciences.
• Hands-on experience with Veeva Vault QualityDocs or a similar Veeva document management application.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience managing controlled documents and electronic document workflows.
• Strong attention to detail with excellent organizational and time-management skills.

Responsibilities

• Manage the creation, routing, review, approval, issuance, revision, and archival of controlled documents within the EDMS.
• Utilize Veeva to manage document workflows, approvals, revisions, and document lifecycle activities.
• Ensure controlled documents are accurate, current, properly formatted, and maintained in accordance with established procedures and cGMP requirements.
• Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other GDP/GxP documentation.
• Coordinate document reviews and approvals with Quality, Engineering, Validation, Manufacturing, and other stakeholders.
• Track documents through the approval process and follow up with document owners and reviewers to ensure timely completion.
• Maintain document histories, revision records, effective dates, and appropriate archival of superseded documentation.
• Perform quality checks of documentation for completeness, accuracy, formatting, and compliance with GDP.
• Assist with document retrieval and preparation for internal audits, regulatory inspections, and project activities.
• Support continuous improvement of document control processes and procedures.

Skills

Document control

Regulatory compliance

Cross-functional collaboration

Attention to detail

Verbal and written communication

Tools

Veeva Vault QualityDocs

EDMS

Microsoft Office

Job description

Verista in West Chester, Ohio is seeking an experienced Document Controller to support document management in a regulated pharmaceutical manufacturing environment. You will manage creation, routing, review, approval, and archival of controlled documents in the EDMS, and ensure GDP/cGMP compliance.

The role requires hands-on Veeva experience, knowledge of cGMP/GDP, meticulous attention to detail, and ability to coordinate with Quality, Engineering, Validation, and Manufacturing teams onsite.