Document Control Specialist II (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 7/20/2018

Job Snapshot

Job Description


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 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.
  • 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.

Experience/Education

  • HS/GED
  • 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.