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

Date Posted: 11/9/2018

Job Snapshot

Job Description


Summary

Under minimum supervision the Document Control Specialist carries out the daily operations of the document Control function and supports project teams in meeting quality and business objectives as they relate to product life cycle management and document control.

Tasks and Responsibilities:

  • The Document Control Specialist facilitates the Change Control process in the electronic change control system as well as tracks the change process through development, approval, and implementation.
  • Analyzes and interprets the significance of the proposed change using independent judgment to identify deliverables, supporting data and approval requirements on a case-by-case basis.
  • Works on problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors.
  • Partners with cross-functional associates to meet compliance requirements.
  • Guide change initiators in the development of accurate changes
  • Ensures changes and documentations are in compliance with the companies policies and procedures.
  • Assists in the documentation of key processes and departmental procedures.
  • Receives, classifies, files, audits, tracks and maintains centralized documentation archiving system of controlled Quality System documents according to established procedures.
  • Responsible for file maintenance and record keeping; locates and retrieves file material upon request from external record archiving location.
  • Compiles data for the creation of metrics and reports for various departmental activities.
  • Assists in the preparation of legacy documents for migration into an electronic document control system.
  • Assist as required in regulatory inspection activities.
  • Assists in the tracking and maintenance of the external standards database
  • Work on continuous improvement projects as assigned by management
  • Effectively follows the company’s standard operating procedures.
  • Exercises good judgment and uses decision making skills to effectively perform job responsibilities.
  • Carries out duties in compliance with established business policies.
  • 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.
  • Perform other duties & projects as assigned.

Education/Experience

  • High School Diploma
  • 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. QSRs, ISO, ISO 13485, CMDR
  • Demonstrate problem-solving and troubleshooting skill
  • Strong verbal and written communication skills
  • Organized and detail oriented

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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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