Quality Assurance Inspector - Knoxville, TN

Overview

Position Title: Quality Assurance Inspector

Business Title: Quality Assurance Inspector

Entity: Consumer Products Services Division

Department: Galbraith

Location: Knoxville, TN

Reports to: QA & Regulatory Manager

FLSA: Non-Exempt

Hours Worked: Typically, Monday through Friday, forty-hours per week. However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary

The Quality Assurance Inspector assists the Quality Assurance and Regulatory Manager in implementing and maintaining various functions of the Quality Management System as assigned.

Duties And Responsibilities

It is everyone’s responsibility to live out our Values and Absolutes

by Shaping a World of Trust while ensuring responsible progress.

• Inspects raw data and reports for conformance to the EPA and FDA Good Laboratory Practices regulations, FDA Current Good Manufacturing Practices and NRC regulations, and logs inspections and findings
• Collects and collates QC data from raw data for analysis by the QA unit
• Runs software programs in Microsoft Word and Excel for the preparation of QAU reports and studies
• Verifies client requests for quality control data and raw sample data
• Maintains Quality Assurance files when appropriate
• Substitutes in other quality assurance functions as necessary, such as raw data clerk duties
• Reviews GMP status of analytical equipment
• Plans, conducts, and reports on internal audits
• Performs regular audit trail reviews of electronic data acquisition systems
• Manages the Approved Vendor List and sends Supplier Surveys requests to suppliers
• Administers Proficiency Tests in accordance with the Proficiency Test Plan
• Prepares QA statements for EPA and FDA GLP inspections
• Support client and company initiatives by providing QA support activities
• Draft audit responses and corrective action project plans to close audit observations
• Inspects and publishes client reports
• Statistically evaluates training data using JMP software
• Follow the guidelines set forth with clients and in the company Quality, Health, Safety, Security and Environmental policies and procedures.
• Comply with company management systems in accordance with appropriate regulatory agencies.
• Follow the guidelines set forth by company Quality Manual and Safety / Chemical Hygiene Plan.
• Other duties as defined by manager, department needs and workload.
  
  

Skills & Proficiencies

• Written and verbal communication skills including the ability to communicate effectively in a group setting, with colleagues and clients
• Organizational and time management skills
• Ability to perform multiple tasks
• Ability to organize and prioritize workload to meet or exceed deadlines
• Individual and Team work ethic
• Proficiency with Windows, Word & Excel
• Attention to detail
• Positive attitude, self-motivated, high level of engagement
• Adheres to company values
  
  

Education And Experience

• Degree requirement: Associates Degree in science, education, or closely related field, and
• Minimum of one (1) year of experience with quality inspections and/or laboratory testing
  
  

An equivalent combination of education and experience may be accepted in lieu of above.