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

Date Posted: 10/13/2018

Job Snapshot

Job Description


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 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
  • • Minimum of three to five years of experience 
    • Must be able to work under minimum supervision 
    • Must possess at a minimum intermediate knowledge of Microsoft Word, Excel and Microsoft Access and other manufacturing systems. 
    • Must possess excellent communication skills, both verbal and written 
    • Ability to handle multiple projects simultaneously and to prioritize tasks 
    • Works well with others in a team environment 
    • Must also be able to maintain confidentiality 
    • Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR 
    • Demonstrate problem-solving and troubleshooting skill 
    • Strong verbal and written communication skills 
    • Organized and detail oriented

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 844-463-6178.




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