GMP Document Controller – GDP & Veeva QualityDocs

Process Alliance; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Process Alliance, Indianapolis, seeks a detail-oriented Document Controller to manage controlled documents within a GMP-regulated pharmaceutical environment. Responsibilities include maintaining Veeva QualityDocs, routing approvals, and ensuring archival integrity.

The role requires a Bachelor’s degree and 2+ years in document control or QA within pharma, with strong organizational skills and proficiency in MS Office. Join a team focused on compliant, high-quality documentation and audits.

Qualifications

• Bachelor’s degree in a scientific/technical, business, or related field.
• 2+ years of experience in Document Control, Records Management, QA, manufacturing, or related pharma function.
• Experience in GMP-regulated environments.
• Familiarity with GDP and document control principles.
• Experience with Veeva QualityDocs or similar electronic document management system.
• Strong organizational skills and attention to detail.

Responsibilities

• Manage lifecycle of controlled documents: review, routing, approval, issuance, revision, distribution, archival.
• Maintain Veeva QualityDocs and ensure documents stay current and compliant.
• Coordinate document reviews and approvals with cross-functional stakeholders.
• Assist with revisions and process improvements for documentation.
• Coordinate periodic document reviews to ensure currency and compliance.
• Maintain traceability and reconciliation of GMP records and forms.
• Support quality systems admin, metrics, and documentation related to quality processes.
• Assist with change controls, deviations, and CAPAs as needed.
• Support audits and regulatory inspections by keeping documentation organized and accessible.

Skills

Attention to detail

Organizational skills

GDP knowledge

GMP knowledge

Cross-functional collaboration

MS Office proficiency

Education

Bachelor’s degree in science/engineering/related field

Tools

Veeva QualityDocs

Microsoft Office

Job description

Process Alliance, Indianapolis, seeks a detail-oriented Document Controller to manage controlled documents within a GMP-regulated pharmaceutical environment. Responsibilities include maintaining Veeva QualityDocs, routing approvals, and ensuring archival integrity.

The role requires a Bachelor’s degree and 2+ years in document control or QA within pharma, with strong organizational skills and proficiency in MS Office. Join a team focused on compliant, high-quality documentation and audits.