Associate, Quality Assurance

AstraZeneca•Philadelphia, PA

About The Position

At AstraZeneca, we bring people on a journey to drive positive change and action. Are you ready to seize the opportunity to bring the best out of our diverse and hardworking teams by navigating different voices and opinions. We promote positive change by involving our people in the process and shifting their approach – we don’t instruct and implement; we work together so people feel they have participated in the process. We instil a Lean perspective amongst our teams, ensuring a common understanding of the value it brings to each person in the team, the business and our patients. Be part of groundbreaking Lean as a tool to promote greater quality and safety, not just speed. The following summarizes key result areas, specific accountabilities and/or tasks, etc. associated with this job title: Support specific Quality Operations processes within assigned area: External audit readiness: Assist, as advised, with preparation for internal and external inspections (e.g., FDA, EMA, other authorities); actively participate in audits, on-floor inspections, and response activities as applicable. Batch record review/approval: Review production records to ensure data integrity and right-first-time execution; partner with Operations to remediate errors and strengthen adherence to production standards. Line clearance and oversight: Perform daily GENBA walkthroughs of Pack Operations, and support areas to verify compliance with GMP processes and standards. Validation review/approval: Support real-time review of validation activities and, as directed, final approval of validation packages, ensuring data integrity and quality-by-design principles. Cross-functional Quality support: Collaborate with other Quality teams on AQL inspections, deviation investigations and CAPA planning, and GDP data review and trending. Operations partnership: Partner with and support Operations on Quality standards and regulatory expectations. Risk and compliance: Assist cross-functional teams with risk management and compliance activities, and contribute to mitigation actions. Continuous improvement: Help implement simplification and improvement initiatives in collaboration with Quality Assurance colleagues. Training and readiness: Contribute to updating training content and support, as directed, training sessions on quality standards, compliance, and inspection readiness for staff at all levels.

Requirements

High school diploma or equivalent
3 years’ experience within pharmaceutical manufacturing
Ability to read, comprehend, and prepare applicable documentation
Basic knowledge of digital tools and applications.
Strong orientation towards learning and implementing newer technologies and digital tools within area.

Nice To Haves

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.

Responsibilities

Support specific Quality Operations processes within assigned area
External audit readiness: Assist, as advised, with preparation for internal and external inspections (e.g., FDA, EMA, other authorities); actively participate in audits, on-floor inspections, and response activities as applicable.
Batch record review/approval: Review production records to ensure data integrity and right-first-time execution; partner with Operations to remediate errors and strengthen adherence to production standards.
Line clearance and oversight: Perform daily GENBA walkthroughs of Pack Operations, and support areas to verify compliance with GMP processes and standards.
Validation review/approval: Support real-time review of validation activities and, as directed, final approval of validation packages, ensuring data integrity and quality-by-design principles.
Cross-functional Quality support: Collaborate with other Quality teams on AQL inspections, deviation investigations and CAPA planning, and GDP data review and trending.
Operations partnership: Partner with and support Operations on Quality standards and regulatory expectations.
Risk and compliance: Assist cross-functional teams with risk management and compliance activities, and contribute to mitigation actions.
Continuous improvement: Help implement simplification and improvement initiatives in collaboration with Quality Assurance colleagues.
Training and readiness: Contribute to updating training content and support, as directed, training sessions on quality standards, compliance, and inspection readiness for staff at all levels.