QC Documentation Specialist: Veeva Vault & GMP Expert

Process Alliance LLC; Indianapolis (IN); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Process Alliance LLC in Indianapolis, IN is seeking a QC Documentation Specialist with a strong QC laboratory background and hands-on Veeva Vault experience to author, revise, and manage controlled documentation in a regulated life sciences setting.

This role partners with QC, QA, Analytical Development, and cross-functional teams to ensure GMP-compliant documentation, create dashboards and reports in Veeva, and drive timely review cycles and change controls.

Qualifications

• Bachelor’s degree in a life sciences or related field required.
• 5+ years of laboratory experience, preferably in QC.
• 3+ years of technical writing in a regulated environment.
• Hands-on Veeva Vault experience with document management and dashboards.
• Knowledge of GMP documentation requirements.

Responsabilités

• Author, revise, and maintain SOPs, test methods, reports, and controlled documents.
• Collaborate with QC, QA, Analytical Development, and SMEs to gather information.
• Create, manage, and update documents within Veeva Vault.
• Develop reports from Veeva to support tracking and compliance metrics.
• Create dashboards and retrieval tools in Veeva to improve visibility.
• Track status, review cycles, approvals, and deliverables to meet timelines.
• Ensure documentation complies with GMP standards.
• Support change control and approval workflows.
• Communicate project status and risks to stakeholders.
• Participate in cross-functional project meetings.

Connaissances

Technical writing

Documentation practices

Communication

Formation

Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Technical Communications, or related field

Outils

Veeva Vault

Description du poste

Process Alliance LLC in Indianapolis, IN is seeking a QC Documentation Specialist with a strong QC laboratory background and hands-on Veeva Vault experience to author, revise, and manage controlled documentation in a regulated life sciences setting.

This role partners with QC, QA, Analytical Development, and cross-functional teams to ensure GMP-compliant documentation, create dashboards and reports in Veeva, and drive timely review cycles and change controls.