Title:  Lead Quality Coordinator

Job Summary

In this role, you will support Incoming Quality functions and inspections for purchased components, raw materials, and finished goods to ensure that all received products meet quality standards and specification requirements. You will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. You will assist the QA Supervisor in the daily scheduling, operation, evaluation and training of QA employees.

Essential Duties and Responsibilities

• Coordinate the receipt, sampling, and inspection of incoming materials and goods

• Perform visual, variable, and functional inspections/testing of incoming materials to verify adherence to specification requirements and enter results within the ERP system

• Review supplier documentation, packaging, labels, and physical product against specifications and purchase requirements to ensure completeness and accuracy of orders

• Compose Non-Conformance Report (NCR) Deviations, Document Change Notices (DCN), Out of Specification (OOS), WorkInstructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).

• Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions

• Determine product acceptability by performing various types of inspections and measurements utilizing varying equipment, such as light inspection booth, color spectrophotometer, FTIR, gages, etc.

• Create, utilize, and maintain testing result forms

• Aid in the development of sampling plans and activities, as required

• Cleaning and maintaining Incoming Quality lab equipment as defined in local procedures and/or instructions

• Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

• Assist Quality management in the creation of procedures and conduct internal audits as required

Education

• High School Diploma for Equivalent

Work Experience

• Minimum 5 years previous experience in Quality Assurance/Quality Control

Preferred Knowledge, Skills and Abilities

• Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
• Experience with ISO 9000 standards and GMP’s
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Motivated self-starter with ability to work independently on multiple assignments in a team environment

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers, or bags of product, using hands and fingers to touch or feel materials or products, and listening for audible tones of equipment. The employee must be able to maintain concentration and visual acuity on tasks for extended periods.
• The employee must perform visual inspection of product, color standards, raw materials, and graphics.  Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification.