We are currently looking to fill a Quality Assurance Specialist position. This position will support Visual Inspection, Assembly, and Packaging operations performed at Regeneron’s internal Fill/Finish facility. This position will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.
Available Work Schedules:
Monday-Friday, 5x8, 2nd shift (12p-8:30p)
Monday-Thursday, 4x10, 2nd shift (12p-10:30p)
In this role, a typical day might include the following:
Oversee programs to support visual inspection, assembly, and packaging operations at the Drug Product facility.
Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls.
Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations.
Execute daily operations, including but limited to:
Providing Quality oversight and guidance during on-the-floor manufacturing
Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards.
Performing quarantine and segregation of material
Performing line clearances activities
Perform Acceptable Quality Level (AQL).
Review and approve procedures, documents and records, including but not limited to Batch Production Records, and Protocols.
Ensure that EBR/Batch Records are complete, accurate, and documented according to written procedure.
Quality support in electronic batch record designed, review, and approval.
Author/Review/Approve Quality documents, such as Standard Operating Procedures (SOP’s), Risk Assessment (RA), training materials, training documents, protocols and reports.
Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Identification and implementation of continuous improvement opportunities within our processes and systems and contribute to the continuous improvement culture.
Maintain project timelines associated with initiatives to support the evolving business.
This role may be for you if you:
Must pass a visual acuity exam, including color assessment.
Must successfully complete the visual inspection training and qualification program.
Capable of building strong interpersonal skills with ability to collaborate on cross functional teams.
Demonstrate ability in problem solving.
Strong organizational skills, including to follow assignments through to completion.
Ability to work in a fast-paced and dynamic environment.
Apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes.
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 the following amount 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are 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.
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)