▷ (Apply in 3 Minutes) Associate QA Specialist (Manufacturing Support)

Within this role you will be responsible for providing QA oversight and support to manufacturing activities, performs and leads activities in support of product release in accordance with mandated regulatory requirements, applicable policies and procedures as well as site expectations. This role requires to work shift which includes a mix of days & nights. This is a shift position, including day and night shift. As an Assoc QA Specialist a typical day may include the following: Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including: Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover, Support Inspection readiness, Support SOP/Manufacturing Record review for usability and fitness for use, Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities Performing and leading consultation or advice in alignment with QA policies Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution Representing the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization Performing activities associated with disposition of product (e.g., manufacturing record review, document review, etc.) Reviewing and approves Regeneron controlled documents Reviewing and approves investigations associated with product or processes Continually evaluates Regeneron processes and procedures with an eye toward continuous improvement Participating in internal, regulatory and customer audits Performing additional duties as requested 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. For Specialist level 3 years directly related experience is required and Sr Specialist you must have 5+ years experience relevant 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.