BioSpace is hiring: QA Specialist (Visual Inspection & Packaging) in Town of Eas

QA Specialist (Visual Inspection & Packaging)

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We are currently looking to fill a Quality Assurance Specialist position. This position will support Visual Inspection, Assembly, and Packaging operations performed at Regeneronsa’s internal Fill/Finish facility. It will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas operate to current FDA and International Regulatory Body requirements.

Available Work Schedules

• Monday‑Friday, 5×8, 2nd shift (12p‑8:30p)
• Monday‑Thursday, 4×10, 2nd shift (12p‑10:30p)

Typical Day Responsibilities

• 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 Regeneronsa controls.
• Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations.
• Execute daily operations, including:
  • 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 clearance activities
  • Determining Acceptable Quality Level (AQL)
• Review and approve procedures, documents and records, including Batch Production Records and Protocols.
• Ensure that EBR/Batch Records are complete, accurate, and documented according to written procedure.
• Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on‑site inspections.
• Identify and implement continuous improvement opportunities within 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 follow‑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 (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves; use of sanitizing agents during gowning process including IPA).
• Ability to remove jewelry, make‑up and nail adornments when wearing cleanroom attire.

Role Requirements

To be considered for this role you must hold a Bachelors degree in Life Sciences or a 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 the education requirement. Level is determined based on qualifications relevant to the role.

Benefits Summary

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 Regeneronsa benefits in the U.S., please visit Regeneron Total Rewards. For other countries specific benefits, please speak to your recruiter.

Equal Opportunity Employer

Regeneronsa 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.

Salary Range (Annually)

$62,355.00 – $128,700.00

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