Quality Assurance Inspector - Knoxville, TN

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.