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.
30+ days ago