AstraZeneca · 15 hours ago
Associate, Quality Assurance
US - Philadelphia - PA
Full-time
Onsite
Mid Level
3+ years expAstraZeneca is committed to driving positive change and action through collaboration and teamwork. The Associate in Quality Assurance will support Quality Operations processes, assist with audits, and ensure compliance with GMP standards while promoting continuous improvement initiatives.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
Review production records to ensure data integrity and right-first-time execution; partner with Operations to remediate errors and strengthen adherence to production standards
Perform daily GENBA walkthroughs of Pack Operations, and support areas to verify compliance with GMP processes and standards
Support real-time review of validation activities and, as directed, final approval of validation packages, ensuring data integrity and quality-by-design principles
Collaborate with other Quality teams on AQL inspections, deviation investigations and CAPA planning, and GDP data review and trending
Partner with and support Operations on Quality standards and regulatory expectations
Assist cross-functional teams with risk management and compliance activities, and contribute to mitigation actions
Help implement simplification and improvement initiatives in collaboration with Quality Assurance colleagues
Contribute to updating training content and support, as directed, training sessions on quality standards, compliance, and inspection readiness for staff at all levels
Qualification
Required
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
Preferred
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
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
Company data provided by crunchbase