Overview:

Position Title: Analytical Scientist, Validation and Qualification

Business Title: Analytical Scientist, Validation and Qualification

Entity: Consumer Products Services Division

Department: Galbraith

  Location: Knoxville, TN

  Reports to: Validation and Qualification Manager

  FLSA: 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 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.