QA Supervisor

Baxters North America; East Bernstadt (KY); On-site; USD 55,000 - 75,000; Full time

Job summary

Baxters North America in Kentucky seeks a Quality Assurance Supervisor to lead the daily execution and continuous improvement of QA programs ensuring compliance with regulations and customer requirements.

On-site role requires supervising QA technicians, reviewing manufacturing records, coordinating with regulatory agencies, and partnering with Operations and Supply Chain to ensure product release meets specs; you will drive root-cause analysis and disposition decisions.

Qualifications

• Bachelor's degree preferred.
• Minimum two years manufacturing experience.
• Strong written and verbal communication and analytical skills.

Responsibilities

• Supervise Quality Assurance Technicians and ensure team is self-sufficient.
• Monitor and review manufacturing records and ensure data availability.
• Coordinate with regulatory agencies and provide inspection/corrective action reports.
• Collaborate with Operations and Supply Chain to ensure specs are met before product release.
• Lead basic and root-cause analysis to support CAPA and corrective actions.
• Manage quality holds, dispositions, rework, and salvage instructions; ensure timely execution.
• Perform other duties as assigned.

Skills

Quality Assurance

Leadership

Regulatory compliance

Documentation

MS Office

Education

Bachelor's degree

Job description

Summary Of Job

Ensures the daily execution and continuous improvement of Quality Assurance programs necessary to ensure compliance with applicable regulations and customer requirements.

Summary Of Job

Ensures the daily execution and continuous improvement of Quality Assurance programs necessary to ensure compliance with applicable regulations and customer requirements.

Essential Functions

• Work must be performed on site.
• Provides direct supervision and leadership to the Quality Assurance Technicians, enabling them to be self-sufficient and directly supportive of business objectives and goals.
• Monitors and reviews records generated by the Manufacturing Process Control and Quality Assurance Technicians. Ensures necessary information (i.e. schedules, quantities, changes, etc.) are available.
• Ensures effective working relationships with appropriate regulatory agencies, including providing inspection and corrective action reports.
• Works collaboratively with Operations and Supply Chain to assure that each area of the manufacturing operation is within the applicable specifications as required by internal and external requirements, prior to authorizing product release for shipment.
• Leads basic and root cause analysis sufficient to provide effective corrective and preventive action reports, in response to Quality System failures, audit non-conformances, customer complaints, and other findings.
• Responsible for managing Quality holds, generating and gaining approval to rework and salvage instructions, and ensuring effective execution of approved disposition in a timely manner.
• Other duties as assigned

Education

• Bachelor of Science degree preferred.

Experience

• A minimum of two years’ experience in manufacturing is required.

Desired Skills

To perform this job successfully, an individual must be able to perform each function satisfactorily. The skills listed below are representative of the knowledge and skills required.

• Strong computer and analytic skills.
• Excellent written and verbal communication skills and presentation skills.
• Ability to develop strong cross-functional relationships within the organization.
• Strong ability to develop relationships.
• Proficiency with MS Office including advanced Power Point, Excel, Outlook skills.