What are the responsibilities and job description for the GMP Documentation Specialist / Technical Writer (M/F/D) position at K-Recruiting Life Sciences?
GMP Documentation Specialist / Technical Writer (M/F/D)
Tasks:
- Author, revise and format GMP documents (SOPs, work instructions, batch records, protocols, reports) in line with internal and regulatory requirements
- Ensure technical accuracy, clarity, and compliance with cGMP and GxP standards
- Collaborate closely with SMEs across Manufacturing, QA, QC, MS&T, and Engineering to capture and structure process information
- Coordinate and facilitate document reviews, incorporating feedback while maintaining document control and version integrity
- Manage the full document lifecycle (drafting, review, approval, periodic review, archival)
- Handle document routing and compliance within eQMS systems (e.g., Veeva, MasterControl), ensuring proper formatting and change control
- Support audit readiness and continuously improve documentation processes
Qualifications:
- Several years of experience in GMP documentation within pharma or biotech environments
- Strong knowledge of cGMP and GxP regulations
- Hands-on experience with SOPs, batch records, work instructions, protocols, and reports
- Proficiency with eQMS systems (e.g., Veeva, MasterControl or similar)
- Solid understanding of document control and lifecycle management
- Experience working cross-functionally with technical teams
- Structured, detail-oriented working style with strong communication skills
- Familiarity with regulatory requirements (FDA, GxP)
Project Details:
Start: ASAP
Duration: 6 months
Workload: 5 days per week
Location: Indiana & remote