Commissioning & Qualification Documentation Lead

Stark Pharma; Lebanon (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is looking for a Commissioning & Qualification Documentation Lead in Lebanon, Indiana. This role involves developing and managing documentation for GMP-regulated projects and requires strong skills in writing, negotiating with vendors, and managing multiple priorities. The position is onsite four days a week and supports critical project timelines in the pharmaceutical industry. Ideal candidates will have experience in GMP manufacturing and documentation management.

Qualifications

• Firm understanding of writing documentation from scratch.
• Experience with CLIAs and URS.
• Ability to manage multiple priorities.

Responsibilities

• Draft, write, and develop commissioning and qualification documentation.
• Manage change controls related to C&Q activities.
• Lead technical discussions with external vendors.

Skills

Documentation writing skills

GMP/Pharma manufacturing experience

Negotiation skills

Team collaboration

Project management

Job description

Overview

The Commissioning & Qualification (C&Q) Documentation Lead is responsible for developing, authoring, and managing commissioning and qualification documentation in support of GMP-regulated projects.

Position details

• Location: Lebanon, IN
• Contract Duration: 3-5 years
• Onsite: 4 days/week
• Required

Qualifications

• Firm understanding of writing documentation from scratch; draft, write and develop CLIAs (change controls) for C&Q;URS experience
• GMP/Pharma manufacturing
• Negotiation with external vendors and internal stakeholders
• Ability to effectively work with other teams
• Capex experience/large projects; ability to manage multiple priorities

Key Responsibilities

• Independently draft, write, and develop commissioning and qualification documentation from initial concept through final approval, including protocols, reports, and supporting records
• Author and manage CLIAs (change controls) related to commissioning and qualification activities, ensuring alignment with site procedures and regulatory expectations
• Lead negotiations and technical discussions with external vendors to resolve documentation, scope, and execution-related issues