R&D Audit - Sr. Associate

What you will do

In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does.

• Data entry into Amgens Quality System of approved audit responses
• Audit resourcing/planning
  • Quarterly Investigator Site audit planning including identifying audit resources through risk assessment of audit targets on a regular basis
  • Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits
  • Updating Audit tracking and accountability tools and distributing/communicating allocations to the audit teams
• Compiling Audit reporting metrics and communication
• Manage Audit documentation and filing

• Supporting outsourced audits by:
• Supporting outsourced audit resourcing/planning for Audits
  • Provide necessary tools, reports/documentation, and access to systems for outsourced Audits
  • Review initial draft audit reports, audit responses and debrief slides.
  • Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings
  • QC Data entry into AMS of audit findings
  • Confirming data entry into RDCS of approved audit responses
  • Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports
  • Provide guidance and resolve queries from external Audit vendors
  • Weekly Meeting with external audit vendor to review tasks and status of audits
  • Communicate noncompliance to Manager
  • Administrative Support (includes maintaining & updating distribution lists and templates)
• Data entry/QC in to the Audit Management System (Trackwise) of audit findings
• Administrative support for audit resourcing/planning
• Manages Audit documentation and filing
  • Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable
• Follow up with CAPA Owners for completion dates and objective evidence
• Review and Append Objective evidence in Amgens Quality System and close record

Basic Qualifications:

• Masters degree in Life sciences or related field

Preferred Qualifications:

• Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
• Quality Assurance Qualification/Certification (preferred)