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Job Title: Analytical Method Validation Specialist

Hours/Schedule: 9am- 5pm

Type: Contract

Overview

Global pharma company looking to bring on an entry to mid level Analytical Method Validation Specialist to their growing team. Must bring a BS Degree and e xperience with analytical method validation and regulatory method validation requirements.

Responsibilities

+ Write analytical method validation protocol in compliance with all applicable FDA/EU/USDA regulations as well as corporate procedures

+ Provide oversight of validation project and coordinate with laboratory experimental test execution

+ Summarize laboratory validation test results in validation report

+ Collaborate with the area manager(s) for project management, project timelines, regulatory documentation and final reports for submission to the USDA

Requirements

+ Bachelor's degree in a relevant scientific discipline (e.g. Biology, Microbiology, Chemistry, Biochemistry)

+ Experience with analytical method validation and regulatory method validation requirements (USDA, ICH, FDA)

+ Preferred experience in writing change controls and conducting impact assessments

+ Preferred experience with Indirect Fluorescent Antibody (IFA) Test methodology

+ Working knowledge and basic theoretical understanding of scientific principles (e.g. microbiology, biological chemistry, biochemistry)

+ Laboratory and/or Production facility experience preferred

+ Basic knowledge of pharmaceutical quality

+ Comprehension of Good Laboratory or Manufacturing Practice (GLP/GMP) and other applicable regulations

+ Written and verbal communications of technical information

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.