Temp QA Specialist

Regeneron Pharmaceuticals; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals in Raheen, Limerick, seeks a Temp QA Specialist to join the QA Operations Batch Review team, contributing to quality oversight in manufacturing and supporting rapid, compliant production.

The role involves reviewing manufacturing records, triaging non-conformances, leading investigations, and partnering with cross-functional teams to resolve issues, while mentoring others in QA processes.

Qualifications

• Experience with QA oversight in pharmaceutical manufacturing and real-time decision making
• Strong documentation and record-keeping for investigations and change controls
• Knowledge of GMP/Regulatory expectations and QA procedures

Responsibilities

• Provide QA oversight and primary quality representation in production areas
• Review and approve manufacturing documentation, area clearances, and changes
• Lead investigations, CAPAs, deviations and root-cause analysis with cross-functional teams
• Mentor and train staff on QA processes, policies, and standards
• Support product disposition, release activities and trend analysis
• Identify opportunities for continuous improvement in quality and efficiency

Skills

Quality assurance

Cross-functional collaboration

Regulatory knowledge

Documentation

Education

BS/BA in scientific discipline or related field

MS in scientific discipline or related field

Job description

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

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.

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.