QA Specialist, Internal Bulk Batch Review
$92.2k - $150.6kRegeneron Pharmaceuticals, Inc.
Quality Assurance Specialist role supporting bulk batch review and product disposition activities within pharmaceutical manufacturing. Responsibilities include batch record review, deviation management, cross-functional collaboration, and process improvement in compliance with cGMP and company standards.
Responsibilities
- Represent QA in deviation, change control, and CAPA investigations and problem resolution
- Review completed batch records and collaborate cross-functionally to resolve manufacturing issues
- Support product disposition activities including document review, labeling, and shipping
- Train and mentor junior staff on processes, procedures, and quality standards
- Evaluate and recommend improvements to manufacturing processes and procedures
Requirements
- Bachelor's degree in scientific discipline or related field
- 2-6 years relevant quality assurance or manufacturing experience (level-dependent)
- Understanding of biologics manufacturing operations
- Strong written, verbal, and interpersonal communication skills
- Proficiency with computerized systems and data management
- Ability to manage multiple priorities and meet deadlines
Compensation: $92,200–$150,600 annually
Vacancy posted 1 day ago
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