Senior Quality Specialist

General

Summary:

The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs s role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.

• Reviews executed batch records and provides customer approval for quality tasks for externally manufactured products
• Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures
• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
• Support the day to day management of the batch release process.
• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.
• Communicates proactively with internal and external partners and management.
• Maintains files such that documents are readily available and easily retrievable.
• Assists department with monthly/quarterly Quality System data review metrics and reporting
• Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience
• Experience providing QA support and oversight of GMP manufacturing operation
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, Track Wise, Veeva
• Knowledge of current industry trends and ability to use the latest technologies.

• Strong communication and influencing skills.
• Critical Thinking / Problem Solving.
• Ability to evaluate quality matters and make decisions utilizing risk based approach.
• Proficiency in using Microsoft Office applications.
• Some experience with, Cell and/or Gene Therapy QA experience, working knowledge of aseptic processing, and quality metrics, dashboards, analysis and improvement programs.
• Some experience providing QA support and oversight of GMP manufacturing operation.
• Some experience successfully participating in event investigations, Root Cause Analysis and CAPA.
• Basic knowledge of current industry trends and has the ability to use the latest technologies.