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Project Scope: GMP Documentation & QMS Support
We are seeking 5 experienced contractors to support GMP documentation and QMS-related activities within a regulated manufacturing environment. The role is split across two core workstreams:
1. GMP Documentation
Author, revise, and format controlled GMP documents, including SOPs, work instructions, forms, batch records, protocols, and reports in line with internal standards and eQMS requirements
Ensure all documentation is technically accurate, clear, concise, and aligned with regulatory expectations and internal procedures
Collaborate closely with cross-functional SMEs (Manufacturing, QA, QC, MS&T, Engineering) to capture accurate process and system information
Facilitate document review cycles, incorporating feedback while maintaining version control and document integrity
Route documents through the electronic QMS (eQMS) in compliance with internal procedures
Ensure proper formatting, numbering, references, and change history documentation
Support the full document lifecycle: drafting, review, periodic updates, and archival
2. Deviations & QMS Records
- Support deviation investigations (e.g., Environmental Monitoring excursions), CAPAs, change controls, and risk assessments by preparing clear, high-quality technical documentation
- Ensure consistency and traceability between source data, executed records, and final approved documents
- Assist with remediation activities and inspection readiness by revising or creating compliant documentation
Qualification:
Must have prior hands-on experience working in cGMP-regulated environments
Proven experience in GMP documentation (SOPs, batch records, protocols, etc.)
Experience supporting deviations, CAPAs, and broader QMS processes
Strong technical writing skills with attention to detail and regulatory compliance
Ability to work cross-functionally and manage multiple stakeholders
Requirements:
Start: asap
Duration: 3-6 months
Capacity: 5 days per week
Location: Onsite in Indiana, USA
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