Join to apply for the Senior QA Compliance Specialist role at Regeneron.
Within this role you will be responsible for maintaining compliance of site operations including manufacturing, quality systems, quality control, quality assurance, facilities maintenance, materials handling, and QA validation in accordance with regulatory requirements and site expectations.
Responsibilities
* Ensure compliance with all aspects of quality for the site: manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Administer and oversee site quality systems, including deviations, CAPA, change control, audits, customer complaints, and quality risk management.
* Review and approve documents related to quality functions: failure investigations, change control documents, corrective/preventive action documents, standard operating procedures, and other instructional documents.
* Maintain electronic systems for change control and deviation management.
* Monitor and trend metrics associated with site quality systems.
* Participate in continuous improvement initiatives, regulatory and customer audits, and quality risk assessments.
* Collaborate with functional departments to resolve issues and maintain compliance.
* Identify gaps in systems and develop feasible correction plans.
* Train personnel on quality system processes.
This Role Might Be For You If You Have
* Proven experience in conducting on‑site investigations and analysis (GEMBA walks).
* Ability to identify and address operational inefficiencies.
* Track record of implementing process improvements based on workplace engagement.
* Demonstrated respectful behavior at all times.
* Basic working knowledge of Microsoft Office Suite.
To Be Considered For This Position You Must Hold
* For Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in the pharmaceutical or related industry.
* For Senior Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of relevant work experience in the pharmaceutical or related industry.
Benefits
We offer a comprehensive benefits package that may include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic. The company will provide reasonable accommodation for known disabilities or chronic illnesses of otherwise qualified applicants.
Location
Limerick, County Limerick, Ireland.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Finance and Sales; Industries: Biotechnology
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