Senior QA Specialist
AstraZeneca

The Senior QA Specialist role is responsible for maintaining the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. Leads, supports, and provides guidance to other functional teams in Operations, QC, and Quality in areas such as External Inspections & Regulatory Surveillance, Site Self-Inspection Program, Device & Combination Product requirements, GxP Documentation Management, and Annual Product Quality Review. As a QA Compliance Team member, the Senior QA Specialist role provides direct support to the Validation department for the development and execution of the site Validation Master Plan (VMP). In addition, the Senior QA Specialist is a local process champion and regional process champion for applicable Quality business processes.

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

• Support Quality, Compliance, and Operational risks via ownership and continuous improvement of the following business processes:
  
• Self-Inspections
  
• External Inspections & Inspection Readiness
  
• GxP Documentation Management
  
• Quality Management Review
  
• Annual Product Quality Review
  
• Internal Quality Standard Assessments
  
• Device & Combo Products
  
• Validation Coordination
  
• Issue Management and Recalls
  
• Lead and execute the above business processes by applying the AZ Business Process Management (BPM) framework to set priorities, balance resource workload, support/empower decision making, and create high-performing process networks.
  
• Utilizes Lean principles, mindset, and ways of working such as problem-solving, 5S, and visual management.
  
• Provides guidance to the cross-functional working team(s) to ensure compliant and timely execution of owned business processes such as Self-Inspections, Product Quality Reviews, Validation planning & execution, and Quality Management.
  
• Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems. Provides guidance to staff concerning the US and international regulations and compliance issues.
  
• Leads and executes the planning and execution of internal & external regulatory inspections (FDA, EMA, MHRA, etc).
  
• Works directly with the Validation department to provide QA support for the development, execution, and review of validation life cycle documents.
  
• Leads major improvement projects and ability to work independently with minimal guidance from management
  

Essential:
• Bachelor of Science in Biology, Chemistry, Engineering or related fields is required, unless significant relevant professional experience can be substituted.
• Minimum of 6 years of experience in the Biopharmaceutical/pharmaceutical industry
• Minimum of 4 years of experience in Quality Assurance, Quality Control or Validation
• Working knowledge of Quality Information and Documentation Systems.
• Experience in regulatory inspections (FDA, EMA, MHRA, PDMA, etc)
• Experience reviewing and approving validation life cycle documentation.
• Excellent technical writing skills and communication abilities.
• Demonstrated ability to work cross functionally to solve complex problems.
• Self-motivated individual that works independently.
• Strong problem-solving skills
• Ability to lift up to 50lbs.

Desirable:
• A graduate degree is desirable.
• Project management experience
• Six Sigma Certification (Yellow Belt and/or Green Belt)

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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