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Document Control Specialist I (QMS)
Ref No.: 18-11174
Location: San Diego, California
Role: Document Control Specialist I
Location: San Diego, CA
Duration: 3+ Months Contract

Summary:

Under minimum supervision the Document Control Specialist categorizes, scans, files, retrieves and tracks documents using specific classification and organization systems. Specialist is responsible for the orderly recording and keeping of physical records.

Tasks and responsibilities:
• The Document Control Specialist receives reviews and classifies incoming quality systems records and supporting materials.
• Reviews incoming validations for good documentation practices and partners with process owners to ensure documentation errors are corrected prior to scanning.
• Logs incoming documentation such as design history records, validations, CAPAs, lab notebooks, in a centralized archiving system.
• Prepares incoming files for scanning process.
• Creates files, labels and barcodes incoming records.
• Scans Device history Records and uploads electronic files into centralized archiving system.
• Manages verbal and written requests for records.
• Locates, retrieves, and delivers records requested by internal customers
• Prepares files for storage based on the company's record retention policy.
• Prepares records for destruction as defined in the company's record retention policy.
• Responsible for inventory transactions such as checking in/out original records, resolving issues and tracking past due items.
• Performs technical and clerical assignments involving data entry, proofing and other administrative duties.
• Demonstrates a sense of urgency and timeliness for assuring optimal record management.
• Carries out duties in compliance with established business policies.
• Assists in regulatory inspection activities
• Demonstrates commitment to the development, implementation and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred educational background:
High school degree

Preferred experiential background:
• One year experience with records and/or office environment
• Entry level knowledge of MS Office
• Basic knowledge of QSRs and regulations applicable to FDA and comparable regulatory agencies.