At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

The Quality Assurance Specialist is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Essential Job Functions:

12 Hour Night Shift with rotating days on/off.

• Maintains a high level of understanding of relevant production processes and quality systems
• Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
  • Change Requests
  • Batch Records and associated documentation
  • Product and Component Release transactions in SAP
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • Standard Operating Procedures

• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
• Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects.
• Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.
• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders.
• Collaborates in data analysis and report creation on quality metrics and key performance indicators.

Minimum Requirements:

• Bachelors degree required.  Preferred in Engineering  / Technical or Healthcare related field.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.

Preferred Background:

• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement.
• Multi-site / multi-functional experience.
• 5 + years experience in Quality Assurance.

Internal/External Contacts & Customers:

• PET members
• QA and other support groups within or across sites
• Supply Chain
• Regulatory Affairs

Reporting Relationship:

Direct Reports: 0

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

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.