GMP Documentation Specialist

Job Title: GMP Documentation Specialist – Biologics Manufacturing

Overview:

We are seeking a detail-oriented GMP Documentation Specialist with hands-on experience in biologics manufacturing to support cGMP operations. This is a project-based role focused on creating, reviewing, and managing GMP documentation in a regulated environment.

Key Responsibilities:

• Author, review, and maintain GMP documentation including SOPs, batch records, work instructions, and forms
• Ensure documentation aligns with cGMP standards and regulatory requirements (FDA, EMA, ICH)
• Support document control processes including versioning, change control, and archival
• Collaborate with Manufacturing, Quality Assurance, and other cross-functional teams to ensure accuracy and compliance
• Assist with deviations, CAPAs, and change controls related to documentation updates
• Support internal and external audits by providing documentation and ensuring inspection readiness

Qualifications:

• Bachelor’s degree in Life Sciences or related field (or equivalent experience)
• 3 years of experience in GMP documentation within biologics, pharma, or CDMO environments
• Strong understanding of cGMP regulations and documentation practices
• Experience with document management systems (e.g., Veeva, MasterControl) preferred
• Excellent attention to detail, organization, and communication skills

Preferred Experience:

• Prior experience in biologics or cell/gene therapy manufacturing
• Exposure to regulatory inspections and audit support