Temp QA Specialist

Regeneron; Limerick; On-site; EUR 45,000 - 65,000; Full time

Job summary

Regeneron in Raheen, Limerick seeks a Temp QA Specialist to join QA Operations Batch Review. You will provide QA oversight for manufacturing operations and serve as the primary quality representative in production areas.

You will partner with cross-functional teams to resolve issues, review manufacturing records, support investigations, deviations, CAPAs, training, and product disposition while ensuring compliance and timely release.

Qualifications

• BS/BA in scientific discipline or equivalent with relevant experience.
• Experience in pharmaceutical QA in manufacturing or related environment.
• Knowledge of deviations, CAPAs, change controls and regulatory expectations.

Responsibilities

• Providing QA oversight and support for manufacturing operations, as the primary quality representative within production areas.
• Partnering with cross-functional teams to facilitate issue resolution, including troubleshooting equipment, process, and schedule disruptions, with proper documentation and quality oversight.
• Assessing and triaging potential non-conformances in real time, ensuring information and documentation support investigations.
• Reviewing and approving documentation for routine and non-routine manufacturing activities, including area clearances, incursions, changeovers, and other events.
• Participating in shift meetings and operational discussions, offering QA mentorship and recommendations.

Skills

QA oversight

Cross-functional collaboration

Regulatory documentation

QA investigations

Education

BS/BA in scientific discipline

MS in 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 prioritize, 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.

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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-reward