Supervisor, Quality Control; 2nd Shift

Overview

At West, we’re a dedicated team 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?

In this role, ensure safe, compliant, and efficient operations in the Quality Control department. Will manage directly and closely support the quality inspectors in all areas. He/she will monitor and control the daily activities of quality inspection, testing, documentation review. Responsible for Safety, accountable for ensuring team members’ 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.

• 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.
• Authoring of quality notifications such as deviations and OOS (visual and dimensionnal).
• 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.

• 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.

• Associate’s Degree in Technical or Engineering required.
• Bachelor’s Degree in Technical or Engineering preferred.

• Minimum 5 years previous experience in Quality Assurance/Quality Control required.
• Experience in FDA regulated environment, pertinent to ISO 13485 preferred.

• Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master‑control, SAP.
• Able to comply with the company’s safety policy at…