Sr. Quality Assurance Auditor

Location
San Francisco, California
Posted
Apr 30, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Senior QA Auditor will be responsible for assisting the Senior Director Quality Assurance with the Supplier Management program including performing GMP audits of Contract Manufacturing Organizations (CMO).  The successful candidate will be responsible for scheduling and leading domestic and international audits including internal audits of company facilities and external audits of suppliers. He/she will identify top compliance risks and communicate them to Management. The Senior QA Auditor must be able to function independently with limited supervision.

Responsibilities:

  • Maintain supplier assessment calendar
  • Maintain supplier assessment / audit files
  • Schedule audits
  • Lead external audits of raw material suppliers including Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, and Contract Laboratories  
  • Develop audit plan, conduct quality audit, prepare audit reports and communicate findings, including compliance risk;  follow-up on prior audit recommendations to ensure implementation and compliance
  • Recommend approval or disapproval of suppliers based on compliance assessment
  • Assign consultants to assist and / or perform audits as required
  • Track completion of audit reports, CAPA responses, audit close out
  • Evaluate CAPA responses for acceptability and work with auditee to resolve deficiencies
  • Update Approved Supplier List
  • Prepare monthly reports of completed activities including trend analysis, if required and submit to the Manager, Corporate QA and Senior QA Management
  • Participate in Annual Supplier Management Assessments
  • Support internal inspection readiness activities
  • Support other GXP functions as required

 Qualifications:

  • BA or MS in Biology, Chemistry or related discipline
  • 5-8 years’ experience working in GXP environment
  • Working knowledge of US and EU GMPs, ICH Guidance Documents, USP and Ph Eur
  • Experience with commercial and clinical manufacturing and testing quality processes
  • Previous experience with small molecule and biologics manufacturing
  • Experience with sterile and non-sterile drug product manufacturing and analytical testing
  • Excellent written and oral communication skills
  • Proficiency with Microsoft Word, Excel and PowerPoint
  • Must be efficient, detail oriented and thrives in fast paced work environment
  • Domestic and international travel up to 50%