Analytical Scientist, Validation & Qualification - 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 Analytical Scientist, Validation and Qualification is responsible for activities related to method development and method validation (MDMV) services, storage stability testing, GLP studies, and instrument qualification (IQ/OQ). Provides support to customers and staff by performing the following duties personally, through the activities of the technical services department, department supervisor, or laboratory staff. 

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.

• Coordinates the efficient and timely processing of MDMV, storage stability, and IQ/OQ activities.
• Prepares MDMV, storage stability, IQ/OQ, and GLP study protocols and reports.
• Serves as Study Director, Principal Investigator, and/or Contributing Scientist for FDA and EPA regulated studies.
• Develops, validates, or customizes analytical methods and standard operating procedures for the internal laboratory or external clients.
• Responsible for investigating and resolving complications that arise during MDMV, storage stability, or IQ/OQ processes
• Participates in hands-on laboratory work to perform investigations, develop procedures, and execute method validation protocol experiments.
• Keeps abreast of FDA, EPA, ICH, and USP guidance on method validation, storage stability testing, and IQ/OQ
• Prepares pricing proposals related to MDMV, storage stability, or other assigned projects
• Completes, maintains, and processes pertinent paperwork and records.
• Plans and coordinates levels of support to achieve project completion schedules
• Maintains close contact with clients to manage expectations and meet their needs as they relate to assigned projects
• Responds to customer inquiries on the telephone, mail or e-mail.
• Responsible for the overall work-product, direction, coordination, and evaluation of MDMV, storage stability testing, GLP studies, and IQ/OQ activities. 

Skills & Proficiencies:

• Able to use MS Office Pro and Adobe Acrobat software.
• Able to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. 
• Able to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 
• Able to write complex custom reports and correspondence. 
• Able to read, analyze, and interpret common scientific and technical journals, and legal documents.
• Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
• Able to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, and sampling theory.
• Able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 
• Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 
• Able to define problems, collect data, establish facts, and draw valid conclusions.

Education and Experience:

• Degree requirement: Bachelor's Degree in analytical chemistry or another scientific field.
• Minimum of three (3) years of experience in analytical chemistry.
• Minimum of one (1) year of experience with method development/method validation, GLP studies, IQ/OQ, or stability studies.

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