QA Specialist (Oligonucleotides/VLPs)
Regeneron
5 hours ago
On-site
East Greenbush, NY
Operations
Quality Assurance Specialist (Oligonucleotides/Virus-like particles (VLPs))
Responsibilities:
- Support dispositioning of product and/or raw materials while ensuring compliance with Quality Assurance policies/procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents
- Review and approve batch records from Contract Manufacturing Organizations (CMOs) for bulk drug substance including VLPs and small interfering RNAs (si-RNA)
- Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigations, evaluation, and problem resolution
- Provide consultation/advice aligned with QA policies
- Perform activities associated with disposition of raw materials and product (e.g., receipt, inspection, document review, shipping)
- Review, edit, or approve Regeneron controlled documents
- Review and approve investigations related to raw materials, product, laboratory, facilities, and materials
- Perform status labeling of raw materials and product
- Continually evaluate processes and procedures for continuous improvement
Qualifications:
- Bachelor’s degree
- Relevant experience by level:
- Associate QA Specialist: 2+ years
- QA Specialist: 4+ years
- Sr QA Specialist: 6+ years
- May substitute proven experience for education requirement (level determined by qualifications)
Skills / Role “May Be For You If You”:
- Excel in a quality-driven organization
- Understand VLP or si-RNA manufacturing operations
- Organized with strong attention to detail
- Able to prioritize multiple assignments and changing priorities
- Able to learn and utilize computerized systems for daily tasks
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.
Benefits (explicitly stated):
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), 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.
Responsibilities:
- Support dispositioning of product and/or raw materials while ensuring compliance with Quality Assurance policies/procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents
- Review and approve batch records from Contract Manufacturing Organizations (CMOs) for bulk drug substance including VLPs and small interfering RNAs (si-RNA)
- Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigations, evaluation, and problem resolution
- Provide consultation/advice aligned with QA policies
- Perform activities associated with disposition of raw materials and product (e.g., receipt, inspection, document review, shipping)
- Review, edit, or approve Regeneron controlled documents
- Review and approve investigations related to raw materials, product, laboratory, facilities, and materials
- Perform status labeling of raw materials and product
- Continually evaluate processes and procedures for continuous improvement
Qualifications:
- Bachelor’s degree
- Relevant experience by level:
- Associate QA Specialist: 2+ years
- QA Specialist: 4+ years
- Sr QA Specialist: 6+ years
- May substitute proven experience for education requirement (level determined by qualifications)
Skills / Role “May Be For You If You”:
- Excel in a quality-driven organization
- Understand VLP or si-RNA manufacturing operations
- Organized with strong attention to detail
- Able to prioritize multiple assignments and changing priorities
- Able to learn and utilize computerized systems for daily tasks
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.
Benefits (explicitly stated):
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), 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.