Onsite
Introduction to role:
Are you ready to turn rigorous quality oversight into real-world impact for people relying on life-changing medicines? Do you want to see the outcomes of your work in safe, reliable product reaching patients on time?
As QA Specialist for Finished Product at our College Park site, you will safeguard the integrity of commercial and clinical packaging and labelling activities. You will connect day-to-day batch documentation and deviation management with the broader mission of uninterrupted, compliant supply for patients with rare and devastating conditions. Working closely with cross-functional partners and Qualified Persons, you will ensure our testing, packaging, storage and release processes meet our Quality Management System and all applicable regulations.
Batch Documentation Oversight: Issue and review batch documentation for finished product packaging, ensuring completeness, accuracy and timely progression to release for both commercial and clinical supply.
Deviation and CAPA Leadership: Provide quality input, oversight and guidance to deviations and investigations to drive robust root cause analysis, effective CAPAs and on-time closure in line with QMS.
QP Release Support: Prepare and review the documentation required to support QP certification and release, ensuring data integrity and clear traceability. -
Change and Complaint Management: Manage changes and lead actions assigned to the College Park site from the complaints process, ensuring timely resolution and learning integration.
Quality Metrics and Reporting: Generate, analyze and report quality metrics to aid in risk identification, drive decisions and track progress on commitments.
Document Lifecycle Management: Review and approve SOPs, Packaging Instructions, Work Instructions, technical reports and protocols to maintain current and compliant documentation.
Quality Risk Management: Participate in and provide oversight of risk assessments, ensuring controls are defined, implemented and maintained throughout the product lifecycle.
Document Ownership: Author, review and approve Quality Agreements to align practices, define clear roles and responsibilities, clarify expectations and enable consistent execution.
Inspection Readiness and Support: Lead and support inspection readiness activities; engage confidently with health authority inspectors; coordinate responses and track follow-up to closure.
Continuous Improvement: Identify improvement opportunities across packaging and related operations; influence stakeholders in a matrix environment to embed enhanced ways of working.
Bachelor’s degree in science, engineering or equivalent
3+ years QA experience in international pharmaceutical and/or biotech industry with packaging experience an advantage.
Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization
Strong verbal and written communication skills with well-structured communication and presentation ability.
Experience in finished product packaging and labelling operations within a GMP environment.
Prior support of QP certification and release activities.
Hands-on use of electronic quality systems and eDMS (for example, TrackWise, Veeva, or equivalent).
Participation in EMA, FDA or other health authority inspections and response management.
Proficiency with root cause analysis tools and risk methodologies (5-Why, Fishbone, FMEA, ICH Q9).
Exposure to biologics or rare disease supply chains.
Lean/Six Sigma training or practical continuous improvement experience.
Here, quality is inseparable from patient impact. We work closely with patients and families, letting their lived experience shape how we prioritize, decide and deliver. You will join a collaborative, mission-led environment that blends the focus and pace of a biotech with the reach and resources of a global science leader. Expect unexpected teams in the same room unleashing bold thinking, modern digital quality systems that enable better decisions, and leaders who value kindness alongside ambition. Your expertise will help keep critical therapies flowing, while you grow through real responsibility, cross-functional exposure and the support of colleagues committed to excellence and integrity.
If you’re ready to turn meticulous quality leadership into safer medicines and reliable supply, take the next step and put your impact in motion today!
Date Posted
12-May-2026Closing Date
25-May-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.Want to know if this job is worth applying to?
