The posting
The Quality Assurance Technician Lead is responsible for overseeing daily quality operations on the production floor. The QA Technician Lead coordinates the inspection of commercial and pharmaceutical products at each stage of production, directs technician workflow, supports quality investigations, ensures the integrity of quality findings and records, and serves as a key operational resource to the Quality Manager.
Responsibilities:
- Own daily production-floor quality operations by coordinating inspection activities, prioritizing quality risks, and directing workflow, priorities, and task assignments for Quality Technicians.
- Serve as the primary floor-level quality resource for production personnel, providing guidance on specifications, product defect evaluation, acceptance criteria, inspection requirements, and disposition of nonconforming product.
- Lead floor-level investigations involving nonconformances (NCRs), customer complaints, deviations, and other quality events, including performing root-cause analysis, documenting findings, and collaborating with production and quality leadership on corrective and preventive actions.
- Ensure the accuracy and completeness of inspection findings, quality records, and production quality documentation.
- Monitor production quality performance and identify recurring defect trends, significant nonconformances, process deviations, and compliance risks, escalating findings and recommended actions to the Quality Manager.
- Coordinate containment, segregation, disposition, and rework activities involving nonconforming materials and products.
- Provide daily direction, training, coaching, and technical guidance to Quality Technicians to ensure consistent application of inspection methods and quality standards.
- Collaborate with the Quality Manager to collect, analyze, and organize data supporting audits, investigations, quality performance metrics, and continuous improvement initiatives.
- Ensure compliance with company Standard Operating Procedures (SOPs), ISO 9001 standards, customer specifications, and current Good Manufacturing Practices (cGMPs).
- Maintain a clean, organized, and safe work environment, promoting adherence to safety and cleanliness standards.
- Perform other quality-related tasks as assigned.
With the support of the QA team, the Quality Technician Lead will also perform following as needed:
- Conduct regular inspections across presses, cutting machines, folders, finishing operations, and pack-out stations to ensure product quality and compliance with specifications.
- Conduct inspections of first articles, in-process products, finished product inspections, and final releases to confirm compliance with customer specifications and quality standards.
- Verify the correct packing and labeling of finished product cartons.
- Perform rub tests and barcode scans as needed to validate product durability and accuracy.
- Conduct periodic comparator checks of printed materials to ensure consistency and adherence to quality standards.
Qualifications:
- High School diploma or GED required; equivalent work experience may be considered.
- Minimum 3-5 years quality experience in manufacturing; pharmaceutical, packaging, or printing industry preferred.
- Working knowledge of computer systems, electronic QMS experience preferred.
- Demonstrated experience conducting investigations involving NCRs, CAPAs, deviations, and customer complaints.
- Strong attention to detail and effective written and verbal communication skills.
- Ability to analyze quality data and identify trends requiring corrective action.
- Strong experience interpreting and applying GMPs and ISO 9001 standards.
- Must be able to read a ruler to 1/64”.
- Must be able to sit, stand, or walk for extended periods.
- Ability to lift up to 50 pounds with or without mechanical assistance, and to use hands and fingers in dexterous and repetitive motions.
