Specialist II, QA/QC

Duties:Coordinate activities associated with DR resolution: track status of outstanding DRs; distribute routine status reports to management; organize cross-functional meetings to facilitate investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely DR closure. Gather and summarize investigational data/information and prepare written QA evaluations of investigations. Provide support to otherQA functions as needed.

 

Requirements: Education: BA/BS in the biological, chemical sciences or related field. Experience: At least 5-8 years related technical experience with significant QA experience. Proven ability to express views and opinions clearly, listen well, and accept conflicting points of view. Proven ability as a team player and team leader. Excellent analytical and problem solving skills. The person in this position must be able to communicate clearly to a wide variety of people in various disciplines both within and outside of the company.Strong interpersonal skills. Excellent scientific, technical, organizational, verbal, and written communication skills.Other Skills: Knowledge of quality systems that ensure control of manufacturing processes in accordance with cGMP. Knowledge of FDA and EU regulations, and ISO requirements. Skill in the use of computer systems for data compilation, management, and analysis. Experience with leading team or group projects. Presentation andmeeting organization and facilitation skills desired.

 

 

TO APPLY: Please visit us at www.chiron.com, Career Opportunities; Keyword: 1187BR

 

EOE