Documentation Specialist

OLSA Resources, Inc.; Santa Ana (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading staffing firm in Santa Ana is seeking a Documentation Specialist to ensure compliance with corporate policies. Responsibilities include creating and revising procedures, managing version control, and supporting document integrity. The ideal candidate should have over 5 years of experience in documentation, especially within the medical device sector, and be proficient in Agile document management. This position is crucial for maintaining quality standards in documentation throughout the organization.

Qualifications

• 5+ years of experience, particularly in medical device documentation.
• Strong documentation and editing skills are crucial.
• Proficiency in Agile document management systems.

Responsibilities

• Responsible for compliance with applicable policies and procedures.
• Create and revise procedures for managing compliance.
• Manage version control and document integrity.

Job description

Documentation Specialist(Santa Ana, CA 92705)

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Document creation and revision of procedures to manage compliance during “transition” process
• Document creation and revision of Division level procedures for each Quality subsystem
• Prepares, edits, files, assembles documentation such as reports or technical documents, records, or correspondence.
• Proofreading and verifying own work
• Verify integrity of Change Request packet
• Processing of controlled documents per approved change requests in Agile document management system
• Information mapping of documents
• Responsible for management of version control, resolutions of conflicting changes, and working closely with the document owners to assure all needs are met.
• Track document control and archival metrics for the department.
• Maintenance of documents per corporate record retention schedules
• Serving as the focal point for customer inquires for document requests/usage as it relates to Harmonized Quality System project
• Support initiatives which may include attendance at project meetings

*****5 years plus experience and medical device experience****