QA Specialist- Drug Product (1st shift)

Quality Assurance Specialist (Drug Product) We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions to support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. Available Work Schedules Sunday-Wednesday, 1st shift (4x10) Wednesday-Saturday, 1st shift (4x10) Typical Responsibilities Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team. Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify a path forward for establishment of procedures. Develop, write, review, and approve SOPs, specifications, and other documents (operation and facility SOPs, quality training, batch documentation, etc.). Accountable for maintaining project timelines to support the evolving business. Perform on-the-floor quality review of documents such as equipment logs, training records, testing results, batch records and supporting documents. Review and approval of documents (electronic and paper-based). Execute daily operations per management in a multifaceted environment. Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards. Provide mentorship during on-the-floor manufacturing. Support audits, inspections and investigations. Perform quarantine, segregation of material and line clearances. Contribute to continuous improvement initiatives. This Role May Be For You If You Are able to adjust schedule based on facility start up, filling, and manufacturing needs. Possess the ability to multi-task/own multiple projects while ensuring each is progressing as planned against defined timelines. Are good at establishing relationships and working/collaborating on cross-functional teams. Can develop performance measures and reports to be presented to management which demonstrate progress and status of projects. Are able to gown for an A classification work environment. Gowning and Environment Full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes/booties, latex gloves, and use of sanitizing agents during gowning process including IPA). Ability to remove jewelry, makeup and nail adornments when wearing cleanroom attire. Role Requirements The candidate must hold a Bachelors degree in Life Sciences or related field and meet the following minimum relevant experience: Associate QA Specialist: 2+ years QA Specialist: 4+ years Sr QA Specialist: 6+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Salary Range (annually) $67,400.00 – $110,000.00 Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit For other countries specific benefits, please speak to your recruiter. Regeneron is an Equal Opportunity Employer 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. Application Process The position is required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks. 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. #J-18808-Ljbffr BioSpace