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Document Control Specialist II (QMS)
Ref No.: 18-11173
Location: San Diego, California
Role: Document Control Specialist II (QMS)
Location: San Diego, CA
Duration: 15+ Months Contract

Summary:

Under minimum supervision the Document Control Specialist receives, reviews, categorizes, scans, files, 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.
• Responsible for inventory transactions such as checking in/out original records, resolving issues and tracking past due items.
• Prepares incoming files for scanning process including.
• Scans Device history Records and other quality system records as required per the company's record retention policy.
• Manages verbal and written requests for records and provides front-line support for all internal customers.
• Prepares files for storage based on the company's record retention policy.
• Locates, retrieves and delivers records from onsite and offsite inventory storage such as Iron Mountain.
• Prepares records for destruction as defined in the company's record retention policy.
• Performs technical and clerical assignments involving data entry, proofing and other administrative duties.
• Assists in the documentation of key processes and departmental procedures.
• Work on continuous improvement projects as assigned by management
• Delivers training to junior personnel
• Assists in the supervision of junior personnel
• 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's 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 in records management and/or administrative environment
• Intermediate knowledge of MS Office
• Working knowledge of QSRs and regulations applicable to FDA and comparable regulatory agencies.