R&D Quality Engineer
Atlanta Metro Area, Georgia
- 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.
- Providing support for training system to include but not limited to control of training records, generating training materials, delivering training, etc.
- 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.
- Support internal, corporate and external audits of Atlanta R&D as required.
- General Quality System responsibilities including:
- Complying with, auditing, and training Quality System Good Documentation Practices.
- Fully complying with 21 CFR and international regulatory requirements applicable to area of responsibility.
- Supporting local quality related and/or design control related projects for Atlanta R&D.
- 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.
0-3 years experience in FDA Regulated Industry, preferably Medical Device or pharmaceutical industry
Six Sigma Green Belt certification preferred.
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.