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Sr. Quality Management Systems Admin in Lenoir, NC at APEX Systems

Date Posted: 5/17/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lenoir, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/17/2019

Job Description

Job #:  971048
Apex is seeking an experienced Quality Systems Manager and/or Administrator within the pharmaceutical or medical device industry in the greater Charlotte, NC area.
Contact Stephen Frazer at 704.521.6100 or sfrazer@apexsystems.com. The Senior EQMS Administrator is primarily responsible for maintaining the electronic QMS platform (TrackWise Digital) which supports all Quality Systems to ensure compliance with regulatory and company requirements.
Job Responsibilities
  • Monitor system performance
  • Log tickets with Sparta for system issues and enhancements
  • Work directly with Sparta to resolve system issues
  • Create, update and obsolete user accounts
  • Update user permissions/roles in accordance with module implementation and/or new job responsibilities
  • Create and obsolete items related to the DMS (document types, document sub-categories)
  • Assist in the development and implementation of EQMS modules
  • Work with module owners and system users to develop enhancements
  • Write and/or execute performance qualifications (PQs)
  • Author, review and/or approve EQMS documentation (Validation Summary reports, SOPs, DRs/CAPAs related to the system, Change Controls, memos, etc.)
  • Develop video trainings
  • Write/update user manuals
  • Train system users, as appropriate
  • Metrics
  • Provide support to system users
  • Other duties as assigned

Education Requirements
  • BS/BA degree in a Scientific discipline or Information Technology (IT)
  • Five years relevant experience preferred
  • Or Equivalent combination sufficient to indicate ability to perform duties of the position

Experience Requirements
  • Must be proficient with Excel. Experience with MS Word and Access preferred.
  • Attention to detail is a requirement
  • 5 years’ experience in GMP, ISO or medical device environment preferred
  • Must be able to read and write English, verbally communicate with subordinates, co-workers and management.
  • Must be able to follow instructions, multi-task and handle multiple priorities without undue stress or errors.
  • Must be able to sit or stand for long periods of time.
  • Must have TrackWise experience.

 
 
 
 
 
 
 
 
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 844-463-6178-6178.