Job Description:

Job Summary:Ensure the continuous improvement of the Quality Control (QC) Lab and Charlotte Operations.Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.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 plusEducation 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.