The responsibility of the Document Control Specialist is to administer the document lifecycle (author, approve, implement, revise, archive) of SOPs, forms, engineering and training documents and monitor compliance with the Company’s documentation procedures and requirements. This includes but is not limited to:
- Managing the daily flow, final release and archival of controlled documents through the document management system, and the electronic document control system for the documents being processed
- Preparing electronic document templates.
- Monitoring compliance with the Company’s document control procedures and requirements, investigate deviations and follow up on their correction
- Maintenance of the Employee Training system, monitor the Master Training schedule and assist in training staff in the Company’s processes and associated tools when needed.
- Maintenance of the Equipment Maintenance schedule and assisting in the scheduling and correspondence with outside vendors to ensure required preventative maintenance and calibrations are completed in a timely manner.
- Maintenance of the Non-conformance reporting system, including tracking , data entry and update of master log
- Maintenance of the Planned Deviation reporting system, including tracking , data entry and update of master log
- Reporting on the document control process and status to the Quality Assurance Manager
- Assisting in administrative support and other related tasks as requested by the Quality Assurance Manager
- Candidate must have at least 1-2 years of related experience, experience in performing the duties described is preferred.
- High school diploma or General Education Degree (G.E.D.), AA or BA degree in a related field a plus
- Strong understanding and capabilities in utilizing naming and numbering conventions for receiving, recording, filing, transferring, transmitting, retrieving and archiving documents;
- Must be able to Identify errors, problems, or non-standard situations and suggest alternatives;
- Must possess the ability to understand the underlying document control principles involved and a strong initiative to apply them
- Must possess character traits of being accurate, meticulous, proactive, efficient, self-organizing, a team player
- Must be proficient in common software, particularly MS Office;
- Experience in a Food and Drug Administration (FDA) regulated environment and familiarity with the types of information handled is a plus, knowledge of tissue banking records is a definite advantage
Indeed - 23 months ago
Texas Human Biologics (THB), based out of a state of the art processing facility in San Antonio, Texas, is a biotechnology company who is...