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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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