Quality Assurance (QA) Specialist - Multiple cities

The Specialist is responsible for Batch Record Review quality activities in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring accurate and timely maintenance and review of manufacturing batch record documentation and department procedures and SOPs.
DUTIES AND RESPONSIBILITIES:

•  Responsible for the review and approval of executed batch records.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including change control, deviations, investigations and CAPA management.
• Own change control, deviation and CAPA quality system records on behalf of the department, as needed.
•  Contributes to the goals within the work group.
•  Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
•  Initiates and revises department SOPs.
•  Supports inspection readiness and acts as Subject-Matter Expert during compliance audits and regulatory inspections.
• Able to effectively multitask.