Alexion Pharmaceuticals, Inc. · 2 days ago
QA Specialist II
Bogart, Georgia, United States of America
Full-time
Onsite
Entry Level
2+ years expAlexion Pharmaceuticals, Inc. is focused on building an inclusive environment and is seeking a QA Specialist II. The role involves executing core processes related to internal and external quality, managing deviations, complaints, and supplier quality, as well as coordinating regulatory documentation and supporting process improvements.
BiotechnologyHealthcareHealth CareMedicalTherapeutics
Responsibilities
Execute core processes applicable to own area of internal / external quality (e.g. deviation management system; global complaint management system, supplier management, product quality reviews)
Conduct timely data entry and documentation related to own quality area
Advise on deviations to make batch disposition recommendations to approve or reject batches
Review and approve investigations to ensure root cause is established and relevant CAPAs are in place
Conduct customer complaint investigations and approve investigation reports
Conduct ongoing reviews and approvals of documentation as applicable (i.e. changes within the change management framework; validations and qualifications; product quality reviews, periodic reports, regulatory documents, and change errands)
Provide advice on GxP within the site, with reference to guidelines and regulations
Lead formal and informal training including GMP training
Coordinate referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews
Support process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices
Support data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes
Qualification
Required
HS Diploma with 2+ years of Experience or Entry Level BS Degree with 0+ years of experience in Science/Engineering Field such as Pharmacy, Biology, Chemistry or related field
Experience working with principles and concepts of compliance management related to GxP, SOPs, & SHE requirements
Relevant experience in executing quality management processes within a highly regulated environment
Experience working with digital tools and applications related to QA reporting, documentation, and analysis
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