Overview
Within this role you will be responsible for providing QA oversight and support to manufacturing activities, perform and lead activities in support of product release in accordance with mandated regulatory requirements, applicable policies and procedures as well as site expectations. This role requires working shifts that include a mix of days and nights. This is a shift position, including day and night shift.
Responsibilities
* Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: issue resolution with key stakeholders, serving as Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions; triage of potential non-conformances with necessary documentation for investigation in real time; support of/counter signing annotations; performing area walkthroughs; providing oversight and review of documentation for non-routine work (Area in PAAS, incursions, changeover); supporting inspection readiness; supporting SOP/manufacturing record review for usability and fitness for use; participating 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 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 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).
* Reviewing and approving Regeneron controlled documents and investigations associated with product or processes.
* Continuously evaluating Regeneron processes and procedures with an eye toward continuous improvement.
* Participating in internal, regulatory and customer audits.
* Performing additional duties as requested.
Qualifications
* Degree or Master’s degree in a scientific field is required.
* Specialist level requires 3 years of directly related experience; Senior Specialist requires 5+ years of relevant experience.
* Understanding of biologics manufacturing operations is preferred.
* Excellent organizational skills and attention to detail.
* Strong written, verbal and interpersonal communication skills with the ability to interact cross-functionally.
* Ability to prioritize multiple assignments and changing priorities.
* Ability to learn and utilize computerised systems for daily performance of tasks.
To be considered for this opportunity you must have a Degree or Master’s 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.
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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., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, salary ranges are shown per 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 in accordance with applicable laws and regulations. Background checks may include identity, right to work, and educational qualifications verification prior to employment.
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