Associate QA Specialist (EOL)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking an Associate QA Specialist to join our QA Operations Batch Review team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Shift Requirements: 24/7
• Location: Raheen, Limerick

What you’ll do:

• Performing ‘End of Lot’ activities which include, compilation of batch records for a specific lot, performing change control and deviation searches on relevant systems, evaluation of change controls, review and approval of IPC forms, creation of Lot Attribute forms (LAFs).
• Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Reviewing and approving Regeneron controlled documents.
• Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborating with Cross functional teams to resolve issues and maintain compliance.
• Monitoring and trending metrics associated with site quality systems.
• Actively participating in continuous improvement ideas, initiation, and implementation.
• Participating in internal, regulatory and customer audits.
• Training personnel on quality system processes.

The environment and physical rhythms of this role:

• You have excellent organisational skills and attention to detail.
• You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally.
• You have the ability to learn and utilise computerised systems for daily performance of tasks.
• You have the prioritise, manage multiple tasks, and meet deadlines.

Let’s find out if we’re a fit:

• Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement.

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€37,000.00 - €59,400.00