Summary: The Sr. QA Specialist works closely with the Associate Director of Corporate Quality to assist with maintaining the Internal and External Audit Programs including maintenance of the Technical Quality Agreement System and supporting Regulatory Agency Inspections, as required. The Sr. QA Specialist will also assist with Product Complaint Investigations as well as compiling metrics for presentation to the Corporate Quality Council. Requirements:
- BS degree in Biological Science, Chemistry, Engineering or related field
- 3-5 years experience in Quality Assurance (auditing experience desired)
- Excellent verbal and written communication skills
- Ability to work collaboratively in a cross functional team environment
- Ability to travel domestically and internationally (travel 10%)
- Knowledge of FDA, ICH, Health Canada, EMA regulations as related to pharmaceutical manufacturing