Associate Documentation Specialist in Irvine, CA at Apex Life Sciences

Date Posted: 8/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/10/2018
  • Job ID:
    876058

Job Description


Large Medical Device company in Orange County wants to hire an Associate Documentation Specialist! 

Duties:

Ensure appropriate and necessary labeling and documentation to meet quality systems in regulatory requirements, with focus on sustaining products.

Responsibilities:

Review change package against governing procedures interact with departments to complete the change package, and release final change package

Perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)

Assist in the development of solutions for labeling projects, involving: legacy systems, country-specific requirements, and product performance updates in collaboration with business unit labeling managers

Act as technical editor for activities that establish labeling content and instructions for use labeling; including evaluating information input into system to determine necessary content for use in labeling.

Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner Identify risk and may propose new alternatives to resolves critical issues

Participate in process improvement projects

Required Skills:

Good computer skills in usage of MS Office Suite

Good written and verbal communication skills and interpersonal relationship skills

Good problem-solving and critical thinking skills

Experience with project management and project management software tools preferred

Good knowledge and understanding of policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation

Good understanding of medical device documentation development activities

Ability to manage confidential information with discretion

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Adhere to compliance with internal procedures

Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness

Education and Experience:

AS with 4+ years industry experience, OR BS with  2+ years industry experience.

Experience with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet

Experience with project management and project management software tools preferred 

Please send resumes to rellis@apexlifesciences.com

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.