Document Controller

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 is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Position Overview

We are seeking a detail-oriented Document Controller to support documentation and records management activities within a regulated pharmaceutical manufacturing environment. This role ensures controlled documents and records are accurately managed, maintained, and archived in compliance with GMP and Good Documentation Practices (GDP).

Key Responsibilities

• Manage the lifecycle of controlled documents, including review, routing, approval, issuance, revision, distribution, and archival.
• Maintain Veeva QualityDocs and ensure documentation remains current and compliant.
• Coordinate document reviews and approvals with cross-functional stakeholders.
• Assist with document revisions and process improvements to ensure documentation remains current and compliant.
• Coordinate periodic document reviews to ensure documentation remains current and compliant.
• Issue, reconcile, and maintain traceability of controlled production documentation, including GMP forms and batch records.
• Maintain secure storage, tracking, retrieval, and archival of GMP records in accordance with record retention requirements.
• Ensure accurate labeling, indexing, and reconciliation of controlled documentation.
• Provide administrative support for quality systems, including periodic reviews, quality metrics, and documentation associated with quality processes.
• Support document-related activities for change controls, deviations, CAPAs, and other quality records.
• Collaborate with cross-functional teams.
• Support internal audits, customer audits, and regulatory inspections by ensuring documentation is organized, complete, and readily available.
• Assist with inspection logistics, documentation requests, and internal self-inspection activities.

Required Qualifications

• Bachelor’s degree in a scientific, technical, business, or related field
• 2+ years of experience in Document Control, Records Management, Quality Assurance, Manufacturing, or a related pharmaceutical function.
• Experience working in a GMP-regulated environment.
• Understanding of Good Documentation Practices (GDP) and document control principles.
• Experience working with Veeva QualityDocs or a similar electronic document management system.
• Strong organizational skills with exceptional attention to detail.
• Proficiency with Microsoft Office applications.

Qualified applicants must be authorized to work in the United States on a full-time basis. Process Alliance will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Learn more about us:

Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.