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ClinLab Solutions Group

Quality Lead

durham, NC

Check who can apply and the requirements below before continuing.

About this opportunity

ClinLab Solutions Group lists this Quality Lead opportunity in durham, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.

Job description

The Quality Supervisor is responsible for leading the production quality team, ensuring that Carolina Components Group follows CCG, ISO 9001, and cGMP standards while attaining company goals. The role of the Quality Supervisor is to provide support to CCG customers, the CCG team, and the quality management system.

Essential Duties and Responsibilities

Manages the daily operation of CCG Quality through the Quality Inspectors and Quality Associates including:

Set schedules and prioritize workload assignments to maintain order fulfillment requirements.

Develops and achieves targeted metrics.

Monitoring and ensuring stock of quality consumables.

Managing personnel shift scheduling, time off requests, employee reviews, and employee disciplinary actions as needed and in accordance with HR.

Oversees staffing levels and hiring.

Maintains positive employee relations, including problem resolution process.

Responsible for compliant, effective inspection, review, and release of job orders; product shipments; in-coming material receipts; product labels; in-process production; receiving and QC data; and final production documentation.

Enforces the adherence to the quality systems to be compliant with company policy and procedures as well as industry standards through annual product and management reviews, complaints, investigations, root cause analysis, corrective and preventive actions, material compliance, and training.

Authors, reviews, and ensures Standard Operating Procedures and Work Instructions are relevant and current within the area of responsibility.

Ensures compliance of the calibration, preventive maintenance, and training programs.

Attends and provides input to relevant production meetings.

Proposes, implements, enforces, and drives continual quality improvements throughout the organization.

Responsible for compiling data relevant to departmental metrics and reports as requested.

Review and approval of product drawings for implementation in production.

Troubleshooting and problem solving for daily order processing.

Performs other duties as assigned.

Desired Education & Experience

4-6 years of industry experience working in a Quality Capacity

2-4 years of leadership experience OR an associate or bachelor’s degree in a related field preferred

Minimum of 3-5 years’ experience in an ISO and/or equivalent quality assurance/control environment (ISO:9001, ISO:17025, ISO:13485, cGMP, FDA, etc.)

Cleanroom and/or manufacturing environment experience

Lean and/or six sigma experience

Certifications such as: ASQ Auditor, CQE, CQPA and Six Sigma are highly desirable.

Desired Knowledge, Skills, and Expertise

Ability to work cross-functionally with other business departments.

Excellent communication and leadership skills

Proficiency in digital systems including Microsoft Office, Acumatica, Qualio, & Noverant

Proficiency in data analysis, preparing, and analyzing results.

Excellent organizational skills

Ability to address, communicate, and implement changes quickly and effectively.

Ability to work in a high-intensity, fast-paced environment.

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Worksite address

durham, NC, 27703, US

Who can apply

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