We are currently looking to fill a Quality Assurance Specialist (Batch Disposition) position. This position performs activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
In this role, a typical day might include the following:
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Review of data in LIMS to perform QC CofA review
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Review and approval of QC Virology CofAs
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Represent disposition in support of onboarding new modalities and product forms
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Assess change controls in support of LAF creation
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Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in, and/or ownership of, investigations, evaluations, and problem resolution
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Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; collaborate closely with external partners and provide input on regulatory communications
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Participates in IOPS cross-functional meetings to achieve standard lead time targets for disposition of drug substance and drug product
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Train and/or mentor junior employees, including providing insights and education on processes and procedures
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Provides consultation or advice in alignment with QA policies
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Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
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Author and facilitate cross functional coordination for updates and revisions to disposition standard operating procedures, work instructions, and job aids
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Review, edit, or approve Regeneron controlled documents, to include certificates of analysis, manufacturing records, and external partner/contract records
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Participate in investigations associated with product
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Perform status labeling of product
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Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
This role may be for you if you:
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Excel in a quality driven organization
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Have an understanding of biologics manufacturing operations, quality control laboratory processes and associated quality systems is preferred
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Possess good written, verbal and interpersonal communication skills and the ability to effectively and comfortably interact cross functionally
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Can prioritize multiple assignments and changing priorities
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Are able to learn and utilize computerized systems for daily performance of tasks
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Have experience working in a laboratory environment or performing review of quality control test data and/or authoring document workflows
To be considered for this role you must hold a Bachelor’s degree in a scientific field and the following amount of relevant experience for each level:
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QA Specialist – 4+ years
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Sr QA Specialist - 6+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#REGNQA
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.S.-based 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.
Salary Range (annually)
$65,100.00 - $124,300.00
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