Job Role: Quality Assurance Specialist
Location: Cork, Ireland
Job Overview:
BioMarin is a world leader in delivering innovative therapies that provide meaningful advances to patients with rare genetic diseases.
These conditions are often inherited, difficult to diagnose, progressively debilitating and have few treatment options. BioMarin continues to focus on advancing therapies that are the first or best of their kind.
The Technical Operations group at BioMarin creates drugs for use in clinical trials and scales production for the commercial market.
As a Quality Assurance Specialist, you will be part of a team that builds and maintains cutting-edge manufacturing processes and sites, provides quality assurance and control to ensure regulatory compliance, and procures goods and services to support manufacturing.
You will work closely with cross-functional teams to promote Quality across activities relating to Quality to meet business priorities.
Key Responsibilities:
* Ensure Lot Release (Drug Substance and Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
* Compile Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
* Support Secondary Packaging Operations including performance of AQL inspections during routine operations.
* Provide Quality direction and oversight of process development and continuous improvement to meet customer needs.
Requirements:
* Degree or 3rd level qualification in Science or Quality.
* Demonstrated experience in Lot Release and Secondary Packaging as Quality contact for the area.
* Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that satisfies the role's requirements.
Desirable Qualifications:
* Lot Release experience in Drug Substance, Secondary and Final Packed Drug Product areas.
* Experience in execution, documentation, and follow-up of in-process inspections for Secondary Packaging processes.
Behaviours:
* Focus on patient and customer needs.
* Resilient profile with ability to deliver in challenging environments.
* Ability to engage and manage multiple stakeholders to achieve objectives.
Why this role?
This role offers an opportunity to work in a dynamic environment where innovation and quality are key drivers of success.
Our team is committed to delivering exceptional results and making a meaningful difference in the lives of our customers.