Job Name: Documentation Specialist II 
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
 
Job Overview
The Release and Critical Documentation Specialist will be responsible for the generation and review of documentation for the submission, testing, and release of raw materials, culture media/buffers, and excipients.

Responsibilities: Release protocol development, preparing/maintaining appropriate critical GMP documentation. Coordinate and maintain SOP review and approval process Administering various functions within the Learning Management System (LMS) Working with Subject Matter Experts, develop training requirements for Standard Operating Procedures, Analytical Procedures and other training material Utilize templates for SOPs and supporting SOP documents Requirements: Bachelor of Science or equivalent degree in a related field. 4+ yr. Experience Strong Technical Writing Skills Good manufacturing practices experience Ability to manage projects/work to schedule/deadlines Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH)  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.
 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.