QA Document Control Specialist jobs in United States
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BEPC Inc. - Business Excellence Professional Consulting · 3 hours ago

QA Document Control Specialist

BEPC Inc. is a consulting firm specializing in business excellence, currently seeking an experienced QA Document Control Specialist to support Quality Operations. The role involves managing and maintaining GMP documentation within an Electronic Document Management System to ensure compliance and regulatory readiness in a pharmaceutical or biotechnology setting.

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H1B Sponsor Likelynote
Hiring Manager
Paola Borrero
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Responsibilities

Manage and maintain controlled documents in the Electronic Document Management System (EDMS), ensuring adherence to established document lifecycle procedures
Independently review SOPs and forms, providing feedback and recommendations to authors to ensure compliance with internal document control standards and best practices
Track controlled documents to ensure timely review, approval, and archival within the EDMS
Coordinate document review, finalization, issuance, and archival of policies, procedures, and other controlled documents
Serve as an EDMS administrator, including user account management, system configuration, troubleshooting, and coordination with EDMS vendors
Manage EasyVista (EV) tickets related to EDMS incidents and service requests, ensuring timely resolution and closure
Provide site training on EDMS workflows prior to granting user access
Manage physical and electronic file room inventory, including scanning, filing, and coordination with offsite archival vendors
Train and provide oversight to document control contractors supporting EDMS processing, issuance logbooks, notebooks, and batch records
Edit and proofread controlled documents for formatting consistency, template adherence, and compliance with quality system requirements
Provide documentation support during audits, inspections, and regulatory submissions
Utilize advanced Microsoft Word processing and MS Office automation features to support documentation efficiency
Support multiple document control projects simultaneously and adapt to changing priorities

Qualification

Veeva Quality DocsGMP documentationEDMS administrationFDA regulatory requirementsMicrosoft OfficeCommunication skillsAttention to detailOrganizational skillsCritical thinking

Required

Bachelor's degree (BS/BA) in Biology, Chemistry, Engineering, or a related scientific discipline, or equivalent experience
2–5 years of experience working with documentation in a regulated industry (pharmaceutical, biotech, medical device, or similar)
Hands-on experience with document control systems (Veeva Quality Docs strongly preferred)
Strong understanding of GMP concepts and documentation requirements
General understanding of FDA regulatory requirements related to documentation
Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook), with strong Word formatting skills
Excellent written, verbal, and interpersonal communication skills
High attention to detail with the ability to perform accurate, compliant, and complete work

Preferred

Experience administering or supporting EDMS platforms (Veeva, EasyVista, or similar)
Ability to automate documentation processes using MS Office tools
Strong organizational, planning, and time management skills
Ability to adapt to frequent changes, shifting priorities, and tight timelines
Proven ability to work independently while collaborating effectively with cross-functional teams
Critical thinking and problem-solving skills related to documentation and quality processes

Company

BEPC Inc. - Business Excellence Professional Consulting

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BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.

H1B Sponsorship

BEPC Inc. - Business Excellence Professional Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2020 (3)

Funding

Current Stage
Growth Stage

Leadership Team

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Oscar Casillas
President and CEO
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Andrew Casillas
Human Resources Partner
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Company data provided by crunchbase