This role is a 12 month fixed-term contract

This is what you will do:

The QA Specialist for Quality Operations will be responsible, with management support, for providing oversight of quality activities associated with documentation of the Finished Product packaging activities for commercial and clinical product at the College Park facility. He/she is responsible for ensuring that testing, packaging, labelling, storage of Alexion products comply with QMS and all applicable regulations.

You will be responsible for:

Perform issuance and review of batch documentation, management of changes, complaints, deviations, and annual product quality reviews related to College Park operations.
Support the QP team, in relation to preparation and review of the relevant documentation for QP release
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.
Generation and reporting of quality metrics
Review and approval of functional area documentation (SOPs, PIs , Work Instructions, technical reports and protocols)
Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
Author, Review and Approval of QAGs
Leading 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, to monitor progress of follow up

You will need to have:

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.

Date Posted

11-Mar-2026

Closing Date

24-Mar-2026

Our 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.

QA Specialist – Finished Product (12 Month FTC)

Job Description