GMP Document Control & Compliance Specialist

Organabio,-LL; San Diego (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

OrganaBio is seeking a Document Management Specialist to lead document control in a GMP setting within our San Diego area operations. You will establish policies for storage, sharing, and destruction of records, while ensuring system security, access controls, and regulatory compliance across projects.

Responsibilities include evaluating current systems, drafting SOPs, supporting audits, and collaborating with cross-functional teams to drive process improvements and maintain confidentiality.

Qualifications

• Bachelor's degree in biology or related field.
• 3+ years industry experience within a GMP Quality or Manufacturing environment.
• Experience drafting and revising controlled documents.
• Excellent analytical and technical skills.
• Excellent and creative problem-solving skills.
• Understanding of FDA, EMA, and other GMP regulations.

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.
• Maintains current knowledge of best practices and developments in document management technologies and techniques.
• Maintains client confidentiality as required.
• Supports audits for clients and regulatory agencies through providing requested documents.
• Issues batch records for production
• Controls label stock and issue-controlled labels.
• Assist with labeling of released materials.
• Assists Subject Matter Expert (SME) with providing training for new and existing employees.
• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.
• Works collaboratively with internal and external cross-functional teams.
• Supports the Excellos Labs safety, GMP, and Quality Plan.
• Performs other related duties as assigned.

Job description

OrganaBio is seeking a Document Management Specialist to lead document control in a GMP setting within our San Diego area operations. You will establish policies for storage, sharing, and destruction of records, while ensuring system security, access controls, and regulatory compliance across projects.

Responsibilities include evaluating current systems, drafting SOPs, supporting audits, and collaborating with cross-functional teams to drive process improvements and maintain confidentiality.