QC Documentation Specialist | Veeva Vault & GMP Expert

Process Alliance LLC; Indianapolis (IN); On-site; USD 65,000 - 100,000; Full time

Job summary

Process Alliance LLC is seeking an experienced QC Documentation Specialist to lead documentation activities in a regulated life sciences setting. You will author and revise SOPs, test methods, and technical reports, ensuring GMP compliance and robust document control within Veeva Vault.

You will collaborate with QC, QA, Analytical Development, and other SMEs to gather information, generate reports, and develop dashboards for visibility and metrics.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Technical Communications, or a related field.
• 5+ years of laboratory experience, preferably within a QC environment.
• 3+ years of technical writing experience within a regulated industry.
• Hands-on experience with Veeva Vault, including document management, reporting, and dashboard/view creation.
• Knowledge of GMP documentation requirements.
• Strong organizational, communication, and project tracking skills.

Responsibilities

• Author, revise, and maintain SOPs, test methods, technical reports, work instructions, and controlled documents.
• Collaborate with QC, Analytical Development, Quality Assurance, and other SMEs to gather technical information.
• Create, manage, and update documents within Veeva Vault.
• Develop and generate reports from Veeva to support document tracking and compliance metrics.
• Create dashboards, views, and document retrieval tools within Veeva to improve visibility and usability.
• Track document status, review cycles, approvals, and deliverables to ensure timelines are met.
• Ensure documentation complies with GMP and company quality standards.
• Support document review, change control, and approval workflows.
• Communicate project status, risks, and document progress to stakeholders.
• Participate in project meetings and cross-functional discussions.

Skills

Technical writing

Laboratory experience

Communication

Project management

Education

Bachelor's degree in Life Sciences

Tools

Veeva Vault

Job description

Process Alliance LLC is seeking an experienced QC Documentation Specialist to lead documentation activities in a regulated life sciences setting. You will author and revise SOPs, test methods, and technical reports, ensuring GMP compliance and robust document control within Veeva Vault.

You will collaborate with QC, QA, Analytical Development, and other SMEs to gather information, generate reports, and develop dashboards for visibility and metrics.