Senior Quality Specialist, Technical

📋 Description

• Support the review and progression of qualification and validation documents through established
• Review protocols and reports associated with manufacturing process and analytical test method
• Support change controls related to supplier changes and other technical quality activities.
• Review manufacturing and laboratory investigations, including associated CAPAs and effectiveness
• Support data review for internal and external protocols, reports, and other quality documentation.
• Assist with the review and electronic approval of interim stability reports.

🎯 Requirements

• Bachelor’s degree in life sciences or a related discipline; Chemistry, Biology, Chemical
• Equivalent combinations of education and applicable professional experience may be considered.
• 5+ years of quality experience within the biotechnology or pharmaceutical industry, with exposure
• 5+ years of experience in GMP Quality Assurance, qualification and validation of manufacturing
• Working knowledge of electronic Quality Management Systems; experience with Veeva QMS is a plus.
• Broad understanding of current Good Manufacturing Practices, including applicable CFR, ICH

🎁 Benefits

• Target base pay range of $95,000–$124,000.
• Short-term incentive compensation in addition to base salary.
• Long-term incentive compensation through company stock.
• Premium healthcare, financial, work-life, and well-being benefits for eligible employees and
• Wellness and employee support programs.
• Life insurance and disability coverage.