QA Specialist (Visual Inspection & Packaging) Job at Regeneron in Town of East G

QA Specialist (Visual Inspection & Packaging)

Join us as a QA Specialist (Visual Inspection & Packaging) at Regeneron.

We are currently looking to fill a Quality Assurance Specialist position supporting Visual Inspection, Assembly, and Packaging operations at Regeneron’s internal Fill/Finish facility. This role 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)

Typical Day

• Oversee programs to support visual inspection, assembly, and packaging operations at the Drug Product facility.
• Ensure compliance with regulations, GMP, GDDP, safety and Regeneron controls.
• Develop, update, review, and approve SOPs, specifications, and supporting documents.
• Execute daily operations, including:
  • Providing quality oversight and guidance during on‑floor manufacturing.
  • Executing daily on‑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.
  • Performing Acceptable Quality Level (AQL) assessments.
• Review and approve procedures, documents, and records, including Batch Production Records and Protocols.
• Ensure EBR/Batch Records are complete, accurate, and documented per procedure.
• Support and review electronic batch records.
• Author, review, and approve quality documents such as SOPs, Risk Assessments, training materials, protocols, and reports.
• Represent QA during audits and inspections; may interact with regulatory agencies during on‑site inspections.
• Identify and implement continuous improvement opportunities within processes and systems, contributing to a culture of continuous improvement.
• 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 and collaborating on cross‑functional teams.
• Demonstrate problem‑solving ability.
• Have strong organizational skills and can follow assignments through to completion.
• Can work in a fast‑paced and dynamic environment.
• Apply critical‑thinking skills to ensure quality and compliance with GMP regulations for all area operations and associated processes.

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, including IPA).
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire.

Education and Experience Requirements

To be considered for this role you must hold a Bachelor’s degree in Life Sciences or a related field and meet the following experience requirements for each level:

• Associate QA Specialist – 2+ years
• QA Specialist – 4+ years
• Senior QA Specialist – 6+ years

Experience may substitute for the education requirement. Level is determined based on qualifications relevant to the role.

Salary Range (annually)

$62,355.00 – $128,700.00

Benefits

Regeneron offers comprehensive benefits, including health, dental, vision, life, 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, please visit Regeneron benefits page.

Equal Opportunity Employment

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.

Background Check

Background checks will be part of the recruitment process, conducted in accordance with the law of the country where the position is based, including the type of checks conducted. The purpose of carrying out such checks is to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.