Sr. QA Specialist, Internal Bulk Batch Review

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