Job Title : Senior Quality Assurance Associate
Summary : Looking for an opportunity to work with cutting edge medical devices? My client is an up and coming medical device company focusing on heart failure and bacterial infections. The goal is to provide targeted solutions for patient populations and diseases. They work across a range of therapeutic areas including advanced drug formulation, innovated delivery systems and other Class II and Class III devices. The lead product is to help with treatment of congestion of fluid due to heart failure where oral diuretics were not effective. If this sounds like something you would be interested in, please apply below!
The Senior Quality Assurance Associate will be responsible for :
- Performing QA activities to ensure compliance with US and international regulatory requirements (GMP and GCP).
- Documentation review for release of combination products including manufacturing batch records, stability protocols and certificates of analysis.
- Process internal deviations, investigations, CAPA and change controls.
- Management and tracking external vendor quality events and CAPAs.
The Senior Quality Assurance Associate should have the following requirements :
- Bachelor's Degree in a Life Sciences discipline
- At least 3 years of quality assurance and quality systems experience in life sciences or medical device.
- Worked with CAPA, deviations and investigations.
- Worked with eQMS.
- Teamwork, flexibility and excellent written and verbal communication skills.
If this sounds like something you would be interested in, please apply!