Job Title: Documentation Specialist I
Location: Durham, NC
Hours/Schedule: Mon - Fri 8am - 5pm
Pay Range: $25 - $29.20/hr
Type: Contract, Potential for extension or conversion to permanent
 
Overview
Provide a brief overview about the client (without using the client’s name), what they do and how the fits into their business. Add “sizzle” regarding the position. 3 lines maximum. Example: Leading Biotechnology Company located in NY is hiring Statisticians with 1-3 years industry experience. If you want to be a part of this groundbreaking work, please apply!
 
Responsibilities Provide documentation support for vaccine production activities Review batch record, logbooks and electronic logbooks for errors and partner with Production, Quality and other personnel to correct such errors and provide clarification as needed Support process documentation changes and improvements which includes updates to batch records and standard operating procedures (SOPs) Effectively maintain and use metrics for the manufacturing shop floor execution documentation program Support?process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams
Requirements Bachelor degree in a Science, Engineering, English, Business or relevant discipline OR Highschool Diploma with two years related GMP Biopharma experience Required Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion Critical thinking and problem-solving abilities Working knowledge of cGMPs and of regulatory requirements as they apply to?the vaccine/pharmaceutical industry Working knowledge of documentation administration including the writing, review, and approval of documentation in a GMP industry Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray

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, 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.