Senior Quality Assurance Specialist

Location: San Francisco, CA
Department: Azzur San Francisco, LLC

Job Description

Description
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

Requirements

  • 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.


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