QA Document Management Specialist in San Diego, California at OrganaBio, LLC

OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation.

JOB SUMMARY

The Document Management Specialist manages documents and records of the company.

REASONABLE ACCOMMODATION STATEMENT

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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.
• Communicates and consults with other staff when assessing, acquiring, or deploying new electronic document management systems to ensure smooth transition and minimal disruption.
• Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues.
• Has experience in writing and/or revising Standard Operating Procedures (SOPs) and other Quality/Compliance related documents.
• 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.
• Participates in department meetings and educational programs.
• Performs other related duties as assigned.

WORKING ENVIRONMENT

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to communicate clearly.
• May be required to lift 20 pounds.

QUALIFICATIONS

Education:

• Degree in biology, related field, or equivalent combination of education, training, and/or experience.

Experience:

• 3+ years industry experience within a GMP Quality or Manufacturing environment.

Skills:

• Basic understanding of laws and regulations regarding document management.
• Excellent analytical and technical skills.
• Excellent and creative problem-solving skills.
• Extensive knowledge of Good Manufacturing Practices (GMPs).
• Understanding of how to apply FDA, EMA, and other regions in a GMP manufacturing environment.
• Experience with drafting and revising controlled documents.
• Experience in deviations, CAPAs, and change controls.
• Ability to identify potential equipment or process issues.
• Ability to organize information for multiple concurrent projects.
• Interpersonal skills to establish and maintain professional relationships both internally and externally.
• Works collaboratively with internal and external cross-functional teams.
• Critical thinking, creativity, and innovative thinking.
• Detail oriented with the ability to set priorities and organize daily work requirements.
• Must be able to work both as a team member and independently, as required.
• Proficient in professional communication both written and oral, which is clear and precise.
• Must keep management informed on any compliance and/or operational issues that arise.
• Must be flexible, as production priorities, timelines, and processes can change regularly.
• Integrity and discretion – ability to maintain confidentiality.
• Ability to perform under pressure.

Pay range:, $30 - $37 per hour DOE