Quality Auditor Supervisor

Quality Auditor Supervisor

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity. At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2.

Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary:

In this role, the QC supervisor will be to ensure safe, compliant, and efficient operations in the Quality Control department. He/she will manage directly and closely support the quality inspectors in all areas. He/she will assist QC Manager to build-up a team of competent QC inspector to achieve consistent compliance and timely execution of tasks. Responsible for Safety, accountable for adherence to procedures, quality and schedules on assigned shifts;

promote effective team member/Company relations to help improve team engagement, customer service and Company profits.

Essential Duties and Responsibilities:

• Supervise shift personnel in the quality control department consistent with high safety and quality standards.
• Troubleshoot problems arising on the shop floor in conjunction with quality standards with the appropriate engineering support from Quality Engineering functions.
• Maintain close observation of quality requirements to keep quality management informed of status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
• Promote and support site initiatives including quality safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant team members.
• Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
• Routinely evaluate team member performance and identify training needs.
• Coach and counsel team members for performance, attendance and behavior.
• Participate in the resolution of team members relations issues.
• Review and approve work time in the appropriate timekeeping system.
• Maintain and verify accuracy of the hours each team member has worked.
• Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions.
• Determine product acceptability by performing various types of inspections and measurements utilizing varying laboratory equipment and taking care of valid calibration (internal and external).
• Create, utilize, and maintain testing result forms.
• Develop sampling plans and activities, as required.
• Authoring of quality notifications such as deviations and OOS (visual and dimensional).
• Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Manage the team's performance, conduct performance 1 to 1's, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
• Liaise with internal and external customers and other departments as appropriate.
• Ensure that the QC inspection conducted are performed according to relevant procedures and data reported in compliance with data integrity principles.
• Act as a central point of communication for all departments in respect to product quality issues on the shop floor and ensure that these are escalated appropriately.
• Other duties as assigned.

Additional Responsibilities:

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

Education:

Associate's Degree in Technical or Engineering required. Bachelor's Degree in Technical or Engineering preferred.

Work Experience:

5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration…