The Quality Assurance Supervisor II is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for the manufacturing areas that it supports. The Quality Assurance Supervisor II is expected to work independently and serve as a mentor to other supervisors.

Responsibilities

• Leads a team in the Quality function and is responsible for hiring, setting performance expectations, driving team engagement, providing continuous and on-time performance feedback, developing staff, assisting team in problem-solving, and handling of employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and development of team.
• Provide Quality support on the manufacturing shop floor
• Responsible for supporting Operations efforts in meeting established production schedule
• Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
• Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
• Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
• Responsible for the review and approval of Procedures and Change Requests
• Assist/serve/provide feedback on continuous improvement initiatives/teams
• Reviews and releases batch records
  May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.