QA Specialist-(Batch Release)-Multi Level

Mid-Senior level Not disclosed Ireland Limerick, County Limerick, Ireland

15 days ago

Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

As a Typical Day May Include The Following:

1. Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance
2. Reviewing of QC related release data, Documentation review
3. Completing deviation, change control & batch record reports to support disposition
4. Performing status labelling of product as the need arises
5. Representing Quality Assurance in support of deviations, CAPAs, etc
6. Representing the IOPS organisation on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
7. Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation
8. Providing consultation or advice in alignment with QA policies Review, edit, or approve controlled documents
9. Interacting with various departments to ensure batch release deliverables are met
10. Evaluating Regeneron processes and procedures with an eye toward continuous improvement

This Role Might Be For You If:

1. You have an understanding of biologics manufacturing operations
2. You have excellent organisational skills and attention to detail is essential
3. You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally
4. You have the ability to prioritise multiple assignments and changing priorities
5. You have the ability to learn and utilise computerised systems for daily performance of tasks
6. You have the ability to prioritise, manage multiple tasks, and meet deadlines

To be considered for this opportunity you must have a Degree or Masters in a scientific field. Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! xcfaprz

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.