Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

THIS POSITION IS FOR 2nd SHIFT: M-F 2pm - 10:30pm.

Accountabilities

Support specific Quality Operations processes within assigned area:
• External Audit Readiness - support the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits, inspections, and response process as applicable.
• Self Inspection Program – Assist in developing and driving the site’s annual self inspection plan to ensure Quality standards are being met in advance of external regulatory audits.
• Batch Record Review/Approval – act as the final signatory on production records to protect data integrity and right first time execution of the production records. Partner with operations teams to remediate errors and improve execution of production standards.
• Line Clearance and Oversight – conduct daily walk through inspections (GENBA) of the Aseptic Filling, Pack Operations, and supporting areas throughout the facility to confirm GMP processes and standards are followed.
• Validation Review/Approval – support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design
• Work cross functionally with other Quality teams to support:
  o Acceptable Quality Limit (AQL) Inspections
  o Deviation Investigations and CAPA Planning
  o Quality Risk Management
  o Product Complaint Investigations
  o Change Control Planning and Execution
  o GDP Data Review and Trending
• Partner and support operations functions related to Quality standards and regulatory expectations.
• Provide mentorship and support to cross-functional teams, in risk management, compliance and sharing valuable observations and findings.
• Lead and implement simplification and improvement initiatives in collaboration with other quality assurance colleagues.
• Help update training content and support training sessions focused on quality standards, compliance, and inspection preparation for staff at various levels.
• Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.

Required Skills/Experience
• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, or Chemistry 
• 3 years’ experience within pharmaceutical manufacturing and quality 
• Strong orientation for continuous improvement and process streamlining and optimization. 
• Experience applying Lean principles and motivating change initiatives within a structured framework. 
• Self-motivated individual that works independently.
• Effective communication and interpersonal skills are required.  

Desirable Skills/Experience
• Project management experience 
• Lean manufacturing experience 
• Some experience in business process/ quality system management. 
• Knowledge of/ experience with newer digital tools and technologies related to quality systems management.  
• Regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.

At AstraZeneca, we are driven by a strong connection to our patients. Our mission is to find the best solutions to put our patients first. Here, you will play a critical role in delivering innovative medicines all the way until they reach our patients. We grow with challenges, continuously seeking new ways to deliver life-changing medicines. Our collaborative environment encourages sharing ideas and problem-solving as a team. With constant new products and launches, there has never been a better time to join us.

Ready to make a big impact? Apply now!

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.