QA Specialist Record Review

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking an QA Specialist Record Review 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: 12/7
• Location: Raheen, Limerick

What you’ll do:

• Reviewing and approving of Manufacturing records, Batch sheets, Electronic Batch records, product changeover documentation, Misc. manufacturing protocols, Data review (at source) and Area walkthroughs.
• Participating in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities.
• Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization.
• Reviewing and approving Regeneron controlled documents.
• Continually evaluating Regeneron processes and procedures with an eye towards continuous improvement.
• Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution.
• May represent the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures.
• Participating in internal, regulatory and customer audits.

The environment and physical rhythms of this role:

• You have excellent organisational skills and attention to detail.
• Strong 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)