Senior QA Specialist, Finished Product

Job Title: Senior QA Specialist, Finished Product (FTC)

Introduction to role:
Are you ready to make a difference in the world of biopharmaceuticals? As a Senior QA Specialist at our College Park facility, you'll play a pivotal role in ensuring the quality and compliance of Alexion products. With management support, you'll oversee packaging activities, including NPI/Qualification for Finished Product Commercial and Clinical products. Your expertise will ensure that testing, packaging, labeling, and storage meet QMS and regulatory standards, including cGMP Biopharmaceutical and Medical Device quality standards. Collaborate with various departments and stakeholders to optimize patient supply and drive quality excellence!

Accountabilities:
- Review and approve documentation for packaging technology and equipment validation as required.
- Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled.
- Provide Quality input, oversight, and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS.
- Provide Quality input, oversight, and guidance to Alexion change controls including NPI to ensure they are raised and progressed in a compliant and timely manner according to Alexion SOPs and QMS.
- Review and approval of functional area documentation (SOPs, PIs, Work Instructions, technical reports, and protocols).
- Perform issuance and review of batch documentation and support the QP team in relation to preparation and review of the relevant documentation for batch release and ensure post-release tasks are complete to allow in-country release.
- Author, Review, and Approval of QAGs.
- Author and review relevant chapters of product quality reviews.
- Lead investigation actions assigned to College Park from complaints process.
- Provide support and expertise for inspection readiness activities during health authority inspections including interaction with inspectors, responses to inspection observations, and monitor progress of follow-up actions.
- Support the drive of Quality Culture and support implementation of continuous improvements at College Park in Compliance.
- Act as designee for QA Manager in their absence.

Essential Skills/Experience:
- Bachelor's degree in science, engineering or equivalent.
- 3-5 years QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference.
- 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.

Desirable Skills/Experience:
- Bachelor’s degree required.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives! Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by exceptional leaders. We offer tailored development programs that align your growth with our mission. Here, your career is not just a path but a journey towards making a difference where it truly counts.

Ready to join us on this exciting journey? Apply now to become part of our team!

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