QC Specialist NPI

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

A global biopharmaceutical company seeks a QC Specialist in Dublin responsible for quality oversight in Chemistry and Biochemistry labs. The role involves validation and transfer of test methods, regulatory submissions review, and supporting quality improvements. Ideal candidates possess a B.Sc. in biological or chemical sciences with 4-6 years of experience in cGMP environments. Strong technical skills, leadership capabilities, and proficiency in MS Office are essential. Join us in promoting an inclusive work environment.

Qualifications

• 4-6 years’ experience in quality control in a cGMP environment.
• Experience in writing technical documents and investigations is preferred.
• Project management skills are a plus.

Responsibilities

• Drive validation and transfer of Chemistry and Biochemistry methods.
• Manage Change Control processes and related tasks.
• Represent QC at product and technical team meetings.
• Support management in enhancing the QC strategic plan.

Skills

Technical competency in Chemistry and Biochemistry methods

Excellent communication and interpersonal skills

Ability to collaborate and lead in a matrix organization

Experience in technical issue resolution

Agility and adaptability

Education

B.Sc. degree in biological/chemical sciences or related technical degree

Tools

MS Office software (Word, Excel, Outlook, Visio, PowerPoint)

Job description

This is what you will do:

The QC Specialist is responsible for technical and quality oversight for Transfer and Validation Activities within the Chemistry and Biochemistry Labs.

You will be responsible for:

• Driving the validation and transfer of Chemistry and Biochemistry test methods and test systems in support of in-process and commercial release testing
• Author/ review and approval of laboratory validation protocols /reports as required
• Critically assess test procedures, analytical validation/transfer reports for accuracy and propose improvements/enhancements.
• Perform review of regulatory submissions
• Support the introduction of automation and rapid techniques within Q C and the implementation of analytical changes
• Performing technical review and approval of applicable BDS protocols and reports
• Manage Change Control process and drive implementation of related tasks.
• Providing SME support to the Manufacturing and Tech Services teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness
• Representing QC at product and technical team meetings and support all associated support activities
• Supporting management in continual enhancement of the QC strategic plan
• Drive process efficiencies and develop CI capability, using CI tools to drive and support improvements within QC with a particular focus on new technologies

You will need to have:

• B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry
• Preferable 4-6 years’ experience in quality control /cGMP Quality environment in a biotech, pharmaceutical or bio-pharmaceutical manufacturing environment
• A high degree of technical competency in Chemistry and Biochemistry methos
• Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
• Excellent communication and interpersonal skills
• Proven record in demonstrating agility
• Experience of involvement in technical issue resolution, in a multidisciplinary environment

We would prefer for you to have:

• Experience in writing of technical documents and investigations
• Project management skills.
• High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint.

Date Posted 26-Nov-2025 Closing Date 25-Dec-2025

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.