Document Controller & CQV Engineer - Onsite West Chester

Verista, Inc.; West Chester (Chester County); On-site; USD 59,000 - 85,000; Full time

Benefits offered by this job

401(k) Retirement Plan (Employer Match

Medical, Dental & Vision insurances

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Verista, Inc. in West Chester, OH, seeks an experienced Document Controller to manage controlled documents within a cGMP environment, supporting Quality, Engineering, Validation and Manufacturing teams.

Responsibilities include EDMS/Veeva workflows, document review, revision, archival, GDP compliance, and preparation for audits. The role requires attention to detail, strong communication, and ability to work onsite.

Qualifications

• Previous Document Control experience within the pharmaceutical, biotechnology, or other highly regulated life sciences industry required.
• Hands-on experience with Veeva Vault QualityDocs or a similar Veeva document management application, required.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience managing controlled documents and electronic document workflows.
• Strong written and verbal communication skills with the ability to work effectively across multiple functional groups.
• Proficiency with Microsoft Office applications.

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 procedures and GDP.
• Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other 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• Maintain document histories, revision records, effective dates, and archival of superseded documentation.
• Perform quality checks of documentation for completeness, accuracy, formatting, and GDP compliance.
• Assist with document retrieval and preparation for internal audits and regulatory inspections.
• Support continuous improvement of document control processes and procedures.

Skills

Attention to detail

Time management

Communication skills

Multitasking

Tools

Veeva Vault QualityDocs

Microsoft Office

Job description

Verista, Inc. in West Chester, OH, seeks an experienced Document Controller to manage controlled documents within a cGMP environment, supporting Quality, Engineering, Validation and Manufacturing teams.

Responsibilities include EDMS/Veeva workflows, document review, revision, archival, GDP compliance, and preparation for audits. The role requires attention to detail, strong communication, and ability to work onsite.