We are currently looking to fill a Quality Assurance Specialist (Drug Product) position. This position will 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:
Monday-Thursday, 3rd shift (4x10)
In this role, a typical day might include the following:
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 path forward for establishment of procedures
Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for 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 the 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 (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and following minimum amounts of relevant experience for each level:
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.#REGNQADoes 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)$58,480.40 - $124,300.00