Job Description
The QA Specialist/Sr QA Specialist for External Drug Product Manufacture provides QA oversight to ensure that drug product manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following: Reviewing and approving the following document types, relating to area functions: Master records, Executed records, Failure investigations, Change Control & Partner Notifications, Standard Operating Procedure (SOPs) Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Providing governance/performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Representing Quality Assurance both internal to Regeneron and External with Partners and Contract Manufacturers in support of complex Deviations, Change Controls, CAPAs, etc, including active participation in investigation, evaluation, and problem resolution Training and mentoring junior employees, including providing insights and education on processes and procedures Providing consultation or advice in alignment with QA policies; and develop an understanding of external partner and manufacturers site procedures Performing activities associated with reading product records for disposition (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on site at a partner or contract manufacturer or at a desk Reviewing, editing, or approving Regeneron controlled documents Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement Participating in regulatory and customer audits This role might be for you if: You have strong understanding of aseptic filling and/or packaging operations You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally and cross-organizationally You have the ability to work a varied schedule including off shift and weekends and be able to travel up 25% of time You have proven technical knowledge in drug product manufacturing, product development and validation To be considered for this position you must hold a BS/BA in a scientific discipline or related field (chemistry, biology, or pharmacy preferred). For Specialist level you must have a minimum of 3 years experience and for Sr Specialist you must have minimum of 5+ years directly related QA experience within biopharma or Pharma industry. 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.