R&D Audit – Sr Associate

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Quality Specialist

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does.

• Data entry into Amgen’s 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 Amgen’s Quality System and close record

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a ‘can do’ approach with these qualifications.

Basic Qualifications:

•  Master’s 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)