Quality Assurance Specialist

1 month ago


South San Francisco, United States Planet Pharma Full time

6 month contract - covering for a maternity leave

SSF - onsite 5 days per week

$40 - $50 per hr


Responsibilities

  • Perform daily operations of Quality Systems (Veeva Vault) and Document Control functions to ensure compliance with regulatory and Nkarta requirements.
  • Support projects for implementing new quality systems improvements
  • Assist in in employee training program
  • Maintain and track documentation for GxP projects
  • Ensure compliant, accurate, and efficient control of controlled documents, such as master production records, labels, logbooks, laboratory notebooks, protocols, etc.
  • Support on-site document storage solutions to ensure organization and timely retrieval mechanisms that support routine operations.
  • Develop, write and revise procedures for operation of quality functions.
  • Perform routine audits of Quality Systems logs and records for reconciliation purposes.
  • Scan completed documents to maintain electronic copies of records.
  • Support the development of Quality Systems training materials. Periodically train other staff members on records control procedures.
  • Identify and implement continuous improvement opportunities within the quality management system.
  • Other tasks / projects as assigned by Management.


Qualifications

  • 2+ years of Quality Systems experience within the biotech or pharma industry - REQUIRED
  • Need experience using Veeva Quality Vault (QualityDocs, Training, QMS).
  • Must have experience as an admin in the system or experience with configurations of the system.
  • Good understanding of current Good Manufacturing Practices (GMP) as related to document requirements.
  • Strong MS Office skills (Word, PowerPoint, Excel, and SharePoint)
  • Proven ability to work effectively cross functionality.
  • Good verbal and written communication skills.
  • Good problem-solving, troubleshooting and time management skills
  • Proficiency with Microsoft and Adobe software applications.
  • Ability to work independently with no supervision.
  • Independence and comfort working in the fluid structure of start-up biotech.
  • Quality Assurance experience supporting both development and commercial products is a plus.



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