Department: Azzur San Francisco, LLC
Azzur Group is seeking a highly motivated and talented Quality Assurance Specialist individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously
Essential Duties and Responsibilities
- Participate in the compliance of the local quality system to the GMPs and corporate guidelines
- Assure the respect of the GMPs and Health Authorities requirements at local level;
- Ensure and manage the quality system procedures to guarantee the respect of GMPs and Health Authorities requirements;
- Act directly to findings from the audits performed at the site by the Quality Lead.
- Support internal audits and supplier audits.
- Set inspection requirements, set inspection methods and inspection sampling plans.
- Ensure that Out of specifications, Out of trends, deviations, CAPA, Change controls are addressed and recorded according to cGMP and SOPs;
- Assure, at local level, the execution of the staff GMP training and the respect of the training annual plan;
- Perform and monitoring of the internal action plan and CAPA;
- Participate in the self-inspections as per approved annual plan;
- Participate in the corrective actions at local level the follow up of the Health Authorities and the subcontractor inspections;
- Assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities requirements;
- Assure the escalation to the Site Quality Lead and to the France Quality Lead in case of critical issues
- BS in Engineering, Science or equivalent technical degree.
- 7+ years’ experience in an FDA regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
- Experience with Master control QMS.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Expert working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, and PowerPoint.