Sr. Quality Assurance Specialist

Senior Quality Assurance Specialist role focused on ensuring compliance with regulatory requirements and cGMP standards in pharmaceutical manufacturing. The position involves reviewing production records, conducting investigations, managing audits, and maintaining quality documentation across assigned operations.

Responsibilities

• Review, approve, and track executed production records and investigation documents
• Conduct quality-related investigations and write validation/qualification assessments
• Manage conditional and final release of materials; ensure cGMP compliance of assigned areas
• Host and conduct internal and external audits; participate in regulatory authority inspections
• Write and review annual product reviews, equipment qualifications, and computerized system validations

Requirements

• Bachelor's degree in microbiology, biology, chemistry, or engineering
• 3-5 years of quality assurance experience in pharmaceutical manufacturing
• Thorough knowledge of cGMP in active pharmaceutical ingredient manufacturing
• Excellent written and verbal communication skills
• Proficiency with Microsoft Office 365 and quality management systems
• Detail-oriented with strong project management and prioritization abilities

Compensation: $82,000-$110,000