Job Description


Job Type : Contract-to-Hire

Location/City : GA - Atlanta

Category : Quality

Region : Southeast

Id : 25439


Quality Systems Coordinator

Client will accept either a Perm hire, and or Temp to Perm

M-F 40 hours weekly T/P 6 Months or Direct Placement

This position is responsible for supporting compliance, maintenance, and improvement of the quality management system under direction of the Quality Systems Manager.

Essential Functions

        Provides hands-on guidance and contribution to the effective day-to-day functioning of the QMS.

  • Provides compliance support for manufacturing, R&D, Quality Assurance, and Operations to assure regulatory compliance and appropriate business planning.
  • Provides support to carry out the creation, review, revision, approval and implementation of change orders within the Document Control System.
  • Analyze, trend, and report on employee training compliance data.
  • Assist in the development of quality plans, identifies critical control points and preventive measures, monitors procedure effectiveness, and corrective and preventive actions to ensure the effectiveness of the QMS.
  • Assist with administration of the CAPA system and associated files and databases.
  • Supports internal and external audits.
  • Participates in and where necessary, drives the continuous improvement of the quality processes.

        Support Quality System initiatives such as standard and regulation updates, as required.

        Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.

        Other duties as assigned.

Support all initiatives as identified by Quality Systems Manager and/or Executive Management Team related to the Product and Quality System documents

Skills

        Bachelor degree or equivalent experience.

        3+ years of experience with Quality Systems, preferably within the Medical Device or Pharmaceutical Manufacturing Industry or alike.

        Proficient knowledge of Quality Systems within the Medical Device and/or Pharmaceutical industry

  • Experience in the medical device or pharmaceutical industry including knowledge of FDA and ISO and other related industry regulations required (ie: 21CFR820, 210, 211, ISO 13485, ISO 14971)
  • Excellent written, oral communication, and teamwork skills
  • Ability to manage multiple tasks efficiently
  • Strong organizational skills
  • Computer literate - intermediate to advanced word processing skills; competent in spreadsheet and database application; comfortable in networked environment

        Ability to lift up to 25 pounds

        Bend Stoop reach

        Ability to sit for two hour at a time

        Ability to reach above head below waist

        Correctable vision to 20/20

 


How to Apply:
Please send your resume in Word or PDF format to: ssilvia@gcrtemps.com
Copy and Paste the following job title and code and place it in the subject line of your email so we can identify the job: Quality Systems Coordinator (#25439-MH1639)

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

Apply Online