Senior Quality Specialist

The Operational Area Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management activities for external manufacturing programs. This role will review batch records, deviations, in-process data, environmental monitoring data, QC release testing, and other quality system documentation to support product disposition.

Key Responsibilities:

• Review executed batch records and provide quality approval for tasks associated with externally manufactured products.
• Perform final review of executed batch records and critical system documentation to determine acceptability per standard operating procedures.
• Ensure all required documentation is complete, accurate, and acceptable prior to product or system release.
• Support day-to-day management of the batch release process.
• Assist with facility preparation for quality audits and participate in corporate audits and external inspections.
• Communicate proactively with internal and external partners and management.
• Maintain quality documentation files to ensure records are readily available and retrievable.
• Support monthly and quarterly Quality System metrics reviews and reporting.
• Escalate critical and major findings to Quality Management and monitor key performance indicators in collaboration with Quality Systems and other GxP operational teams.

Required Qualifications:

• Bachelor’s degree in a scientific or allied health field, or equivalent combination of education and experience.
• Experience providing QA support and oversight within GMP manufacturing operations.
• Experience leading event investigations, Root Cause Analysis (RCA), and CAPA activities.
• Experience working with quality systems and applications such as Oracle, Track Wise, and Veeva.
• Knowledge of current industry trends and ability to leverage emerging technologies.