GMP Quality Documentation Specialist

OrganaBio, LLC; San Diego (CA); On-site; USD 41,000 - 51,000; Full time

Job summary

OrganaBio, LLC is hiring a Document Management Specialist to manage company documents and records. You will establish and enforce document storage policies, ensure system security, and support audits and compliance programs across GMP environments.

The role emphasizes SOP creation, workflow improvements, and collaboration with cross‑functional teams to maintain data integrity and confidentiality within a fast‑paced biotech setting.

Qualifications

• 3+ years in GMP Quality or Manufacturing environment.
• Bachelor's degree in biology or related field.
• Experience drafting and revising SOPs and controlled documents.
• Strong understanding of regulatory requirements in GMP environments.

Responsibilities

• Establishes and implements policies and procedures for document storage, sharing, transmission, and destruction.
• Evaluates document management systems to determine effectiveness and suggests improvements.
• Consults with end users to identify problems accessing electronic content.
• Ensures security and revision controls for master documents.
• Supports audits by providing requested documents to clients and regulators.

Skills

GMP knowledge

Analytical skills

Documentation skills

Attention to detail

Communication skills

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in biology or related field

Tools

GMP/Quality systems

Job description

OrganaBio, LLC is hiring a Document Management Specialist to manage company documents and records. You will establish and enforce document storage policies, ensure system security, and support audits and compliance programs across GMP environments.

The role emphasizes SOP creation, workflow improvements, and collaboration with cross‑functional teams to maintain data integrity and confidentiality within a fast‑paced biotech setting.