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

• Deliver 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.
• Provide 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.
• Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities.
• Perform and lead consultation or advice in alignment with QA policies.
• Represent Quality Assurance in support of complex and/or significant deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution.
• Provide training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of the QA organization.
• Perform activities associated with disposition of product (e.g., manufacturing record review, document review, etc.).
• Review and approve investigations associated with product or processes.
• Represent the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures.
• Continuously evaluate 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 utilize computerized systems for daily performance of tasks.
• You are able to 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 the education requirement.

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

Salary Range (annually)

37,000.00 - 59,400.00