GMP Document Control Specialist

OrganaBio; San Diego (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

OrganaBio is seeking a Document Management Specialist to oversee documents and records. The role emphasizes establishing policies for storage, sharing, transmission, and destruction, while ensuring system security and regulatory compliance within GMP frameworks.

You will evaluate systems, consult end users, and contribute to SOP writing and training. This position supports audits and maintains confidentiality across cross-functional teams.

Qualifications

• Degree in biology or related field.
• 3+ years in GMP Quality or Manufacturing.

Responsibilities

• Establishes and implements policies and procedures regarding document storage, sharing, transmission, and destruction.
• Evaluates existing document management systems and procedures to determine current effectiveness and efficiency; identifies and recommends improvements.
• Consults with end users to identify problems in accessing electronic content.
• Ensures security of system and integrity of master documents by implementing document and system access rights and revision controls.
• Ensures company complies with applicable laws and regulations regarding data security and document management.

Skills

GMP knowledge

Document control

SOP drafting

Regulatory compliance

Quality systems

Attention to detail

Education

Biology degree

Job description

OrganaBio is seeking a Document Management Specialist to oversee documents and records. The role emphasizes establishing policies for storage, sharing, transmission, and destruction, while ensuring system security and regulatory compliance within GMP frameworks.

You will evaluate systems, consult end users, and contribute to SOP writing and training. This position supports audits and maintains confidentiality across cross-functional teams.