QC Documentation Specialist

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 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 an experienced QC Documentation Specialist with a strong Quality Control (QC) laboratory background and hands‑on Veeva Vault experience to support documentation activities within a regulated life sciences environment. This individual will be responsible for authoring, revising, and managing controlled documentation while partnering closely with QC, Quality Assurance, Analytical Development, and cross‑functional stakeholders. The ideal candidate combines technical writing expertise with a solid understanding of analytical methods, GMP documentation practices, and Veeva Vault functionality, including document management, reporting, dashboard creation, and document retrieval.

Key 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.

Required 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.
• Strong understanding of analytical methods and laboratory documentation practices.
• 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.

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.