Associate QA Specialist

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:

Delivering QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including: Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations and performing area walkthroughs.

Providing oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover, Support Inspection readiness, Support SOP/Manufacturing Record review for usability and fitness for use,

Participating in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities.

Performing and leading consultation or advice in alignment with QA policies.

Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution.

Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization.

Performing activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)

Reviewing and approving investigations associated with product or processes.

Representing the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures.

Continually evaluating Regeneron processes and procedures with an eye towards continuous improvement.

May participate in internal, regulatory and customer audits.

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

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