Quality Control Continuous Improvement Supervisor

Job Summary:

Ensure the continuous improvement of the Quality Control (QC) Lab and Charlotte Operations.

Supervisory Responsibilities:

• Manages staffing, overseeing hiring, training, and development, while coordinating scheduling, assignments, and workflow.

• Reviews HR platform for accurate employee time logging and approval, maintains records, and manages lab retains.

• Provides guidance, training, and developmental opportunities to QC method development analysts, emphasizing safety. Conducts periodic reviews and offers regular feedback.

• Facilitates cross-training among QC staff and develops training programs for staff.

General Duties/Responsibilities:

• Acts as a liaison on all issues related to QC/Production and QC/raw material supplier interface.

• Supports QC lab daily operations, serves as a backup to the QC supervisor, and ensures the lab is kept clean and orderly in a 5S state.

• Ensures all instruments and analytical equipment are calibrated, maintained, and validated, including coordinating instrument troubleshooting and repair.

• Performs OOS investigations for all production and customer-related non-conformances and performs quality testing as needed to support production or confirm test results.

• Designs necessary experiments, conducts Gage R&R studies, and drives method development, ensuring continuous improvement of QC daily workflow.

• Performs root cause analysis investigations, drives CAPA for operations, and proactively reviews batch records and instructions to lead improvement initiatives.

• Researches, evaluates, and vets new instrumentation, and manages the NIR database, releasing models for use.

• Assists with quality order, D365, and Whiteboard issues, and assists in maintaining ISO 9001:2015, EFFCI, and GMP certifications for the QC lab.

• Assists with inventory management, facilitates the ordering process, and generates work orders as needed for items requiring repair or replacement in the lab.

• Implements Lean Six Sigma methodologies to enhance efficiency and reduce waste within the QC department and drives innovation in QC practices through the adoption of emerging technologies and analytical methods.

• Collaborates with cross-functional teams to integrate quality control standards company-wide and champions a culture of safety and environmental responsibility.

• Develops and maintains the Quality Management System (QMS) to ensure compliance with industry standards, including overseeing the validation and implementation of new laboratory information management systems (LIMS).

• Leads the preparation and readiness for external quality audits, coordinates responses to audit findings, and negotiates contracts and manages relationships with third-party vendors and service providers.

• Establishes key performance indicators (KPIs) to track quality objectives, reports on QC performance to senior management, and prepares and delivers comprehensive training modules on quality standards, procedures, and best practices.

• Manages projects related to continuous improvement in QC Lab and Operations, including testing by special request.

Required Skills/Abilities:

• Excellent verbal communication skills.

• Excellent organizational skills and strong attention to detail.

• Excellent analytical skills

• Clear and effective written and verbal communication skills.

• Proficient with Microsoft Office Suite and Minitab

• Efficient time management skills.

• Ability to read and understand manuals and maintain proper records.

• Ability to collaborate with others and work independently

• Ability to identify key details

• Ability to troubleshoot and solve problems

• Lean Six Sigma Methodology

• Knowledge of ISO9001

• Experience with AI a plus

Education and Experience:

• Bachelor’s degree Chemistry, Engineering, or related field required; Master’s degree preferred

• Three to five years of experience in related field with supervisory experience required.

Physical Requirements:

• Exposure to various chemicals and reagents.

• Prolonged periods of sitting at a desk and working on a computer.

• Must be able to carry 40 Lbs., stoop, bend, squat.