VGXI: Quality Control Document Specialist

This position will be responsible for activities involving quality assurance and compliance with applicable regulatory requirements within the Quality Control Group.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Performs the compliance review and approval of all documentation related to disposition of clinical products and research testing documentation
  • Generation of associated deviations, investigations and OOS reports
  • Generation of change controls
  • Performing routine internal audits of quality control processes
  • Scheduling, initiation and review of stability study data
  • Assisting in all other QC related activities as required
  • Follows Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs)
  • Other duties as assigned or determined by Area Management

QUALIFICATIONS

  • Must have a Bachelor’s degree in life sciences or an Associate’s degree with 3-5 years of relevant experience and/or training; or equivalent combination of education and experience.
  • Experience with in a pharmaceutical/biologics environment is preferred.
  • GMP experience is a plus

Contract to hire position

VGXI is an Equal Opportunity Employer

Quality Control Document Specialist

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