QA Specialist-(Batch Release)-Multi Level

1 week ago

Limerick, Ireland Regeneron Ireland DAC Full time

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: Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance Reviewing of QC related release data, Documentation review Completing deviation, change control & batch record reports to support disposition Performing status labelling of product as the need arises Representing Quality Assurance in support of deviations, CAPAs, etc 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 Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation Providing consultation or advice in alignment with QA policies Review, edit, or approve controlled documents Interacting with various departments to ensure batch release deliverables are met Evaluating Regeneron processes and procedures with an eye toward continuous improvement This role might be for you if: You have an understanding of biologics manufacturing operations You have excellent organisational skills and attention to detail is essential You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally You have the ability to prioritise multiple assignments and changing priorities You have the ability to learn and utilise computerised systems for daily performance of tasks You have the 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 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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