Documentation Specialist I

Company: Joul--
Location: Durham
Posted on: April 25, 2025

Job Description:

Job Title: Documentation Specialist - I

If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
Location: Durham, NC
Hours/Schedule: Mon- Fri 8am-5pm
Type: Contract

Overview
Leading pharmaceutical company looking for an experienced Documentation Specialist. Ideal candidates should have a Bachelors degree or High School Diploma and two years of GMP Biopharma experience. Candidates should have a working knowledge of cGMP's and regulatory requirements as they apply to the vaccine/pharmaceutical industry.

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
Education 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

Keywords: Joul--, Greenville , Documentation Specialist I, Other , Durham, North Carolina