Quality Assurance Analyst supporting process improvement and Quality Management System at BioScript Solutions. Overseeing corrective actions and collaborating with cross - functional teams.
About the role
- QA Analyst ensuring product quality and customer satisfaction at Cytiva. Collaborating on quality records and leading continuous improvements in manufacturing and operational activities.
Responsibilities
- Drive Product Quality and Customer Satisfaction by reviewing and approving quality records, both internal (e.g. NCR, Change Control, risk assessments etc.) and customer facing.
- Collaborate with colleagues to analyze, develop and improve upon quality KPIs to drive Customer Satisfaction.
- Lead continuous improvement initiatives for manufacturing production and QMS processes in collaboration with cross functional teams using process mapping, fishbone diagram, 5S, and other continuous improvement tools.
- Conduct and improve QA Operational activities, such as routine in-coming, in-process and final inspections.
- Develop and deliver training materials to colleagues on procedures, technical writing, and compliance requirements, etc.
Requirements
- A post-secondary degree in Science or Engineering discipline
- 3+ years of quality assurance experience in a biotech industry, medical device, or other relevant experience
- Exceptional analytical, problem solving & root-cause analysis skills for moderate to highly complex issues
- Experience with leading short and long term projects related to process improvements for QMS and QA Operations within ISO 9001 or ISO 13485
- Excellent technical writing, verbal and written communication skills
Benefits
- paid time off
- medical/dental/vision insurance
- retirement benefits
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