Alexion Pharmaceuticals, Inc. · 16 hours ago
Associate, Quality Assurance
Philadelphia, Pennsylvania, United States of America
Full-time
Onsite
Mid Level
3+ years expAlexion Pharmaceuticals, Inc. is committed to driving positive change in the pharmaceutical industry. The Associate, Quality Assurance will support specific Quality Operations processes, assist with audits, ensure compliance with GMP standards, and collaborate with cross-functional teams to maintain quality standards.
BiotechnologyHealth CareMedicalTherapeutics
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
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. 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
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
Company data provided by crunchbase