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R&D Quality Engineer

Atlanta Metro Area, Georgia

Post Date: 09/11/2017 Job ID: JN -092017-19978
Description:
  1. Performing Document Creation, Review and/or Approval for Atlanta R&D records to include but not limited to laboratory notebooks, equipment logbooks, batch records, protocols/reports, etc.
  2. Providing support for training system to include but not limited to control of training records, generating training materials, delivering training, etc.
  3. Support the site supplier management program to include but not limited to generation and maintenance of documentation for the approval of Atlanta R&D suppliers.
  4. Support internal, corporate and external audits of Atlanta R&D as required.
  5. General Quality System responsibilities including:
    1. Complying with, auditing, and training Quality System Good Documentation Practices.
    2. Fully complying with 21 CFR and international regulatory requirements applicable to area of responsibility.
    3. Supporting local quality related and/or design control related projects for Atlanta R&D.
    4. Routine reporting requirements for various compliance forums including Quality Council, Management Review, Quality Plan Performance Meetings, routine dashboard reporting
  • Appropriately processing, evaluation and completion of records to ensure that they meet Company, Novartis and regulatory agency requirements.
  • Processing records in a timely manner.
  • Communicating problems or potential problems with any Quality System area to management.
  • Timely completion of all necessary Quality System metrics.
  • Ensuring all Company driven training is successfully executed for the appropriate Atlanta R&D personnel.
  • Acceptable levels of internal and external customer satisfaction.
Skills:
0-3 years experience in FDA Regulated Industry, preferably Medical Device or pharmaceutical industry
Six Sigma Green Belt certification preferred.
Skills:
Excellent attention to detail and ability to cross-reference documentation from different areas to ensure consistency and compliance to established requirements.
Ability to interpret, analyze, and present technical information using practical judgment.
Familiarity of FDA/EU regulations including cGMPs, new drug/device regulations, other key FDA/ISO guidances, International Council on Harmonization (ICH) requirements and current industry practices.
Computer literacy with Alcon standard software platforms.
Capable of functioning effectively in a team environment.
Excellent written and oral communication skills.
Demonstrated problem solving skills.
Ability to organize and manage concurrent activities.
Demonstrated sensitivity and understanding of cultural differences & diversity issues.
Ability to be trained and to train others. Excellent interpersonal and presentation skills.

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