This position will be responsible for activities involving compliance with applicable regulatory
requirements and internal policies within the Manufacturing Group.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Performs the compliance review and approval of all manufacturing batch documentation
related to disposition of clinical products
Author/Review deviations and investigations
Writing/Reviewing Standard Operating Procedures for manufacturing department
Review Master Production Records
Performing routine internal audits of Manufacturing processes
Write and review protocols for development reports, IQ/OQ’s and validations
Follows Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs)
Other duties as assigned or determined by Area Management
Associate’s Degree or equivalent; or one to three years related experience and/or
training; or equivalent combination of education and experience.
Experience with plasmid purification and microbiology techniques is preferred.
Bioprocessing and GMP experience is a plus.
Contract to hire position
VGXI is an Equal Opportunity Employer.