GMP Documentation Specialist / Technical Writer (M/F/D)
K-Recruiting Life Sciences, Indiana, PA, United States
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)
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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)
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