At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Temp 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:
Location: Raheen, Limerick
What you’ll do:
Providing QA oversight and support for manufacturing operations, serving as the primary quality representative within production areas
Partnering with cross-functional teams to facilitate issue resolution, including troubleshooting equipment, process, and schedule disruptions, while ensuring appropriate documentation and quality oversight
Assessing and triaging potential non-conformances in real time, ensuring required information and documentation are secured to support investigations
Reviewing and approving documentation associated with routine and non-routine manufacturing activities, including area clearances, incursions, changeovers, and other operational events
Participating in shift meetings and operational discussions, providing quality mentorship, observations, and recommendations related to ongoing activities and containment actions
Providing quality consultation and guidance in alignment with QA policies, procedures, and regulatory expectations
Representing Quality Assurance in the management of complex deviations, change controls, CAPAs, and other quality systems, including active participation in investigations, root cause analysis, and corrective action implementation
Supporting employee development through training, coaching, and mentoring on QA processes, procedures, and standards
Performing activities related to product disposition and release, including review of manufacturing records and supporting documentation
Reviewing and approving investigations associated with product, process, and manufacturing events
Identifying opportunities for continuous improvement and support initiatives that improve product quality, compliance, and operational efficiency
The environment and physical rhythms of this role:
Excellent organisational skills and attention to detail
You have the ability to learn and utilise computerised systems for daily performance of tasks
Strong written, verbal and interpersonal communication skills and can optimally interact cross functionally
You have the ability to prioritise, manage multiple tasks, and meet deadlines
Let’s find out if we’re a fit:
Assoc Specialist - BS/BA in scientific discipline or related field or equivalent combination of education and experience
Specialist - BS/BA in scientific discipline or related field with min 3 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
Thrive today. Grow tomorrow.
#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA #REGNQA
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…