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QA Specialist

3 months ago

South San Francisco, United States Planet Pharma Full time

QA Specialist II

SSF, CA

6-month contract

Pay: $40-50/hr


*Candidates must have extensive experience with Veeva*


Responsibilities

  • Perform daily operations of Quality Systems (Veeva Vault) and Document Control functions to ensure compliance with regulatory and 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

  • 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.
  • Previous experience with Veeva Vault is a plus.

Experience/Education

  • Bachelor's degree with 2 years relevant experience in managing documentation in a regulated industry preferred. Work experience in lieu of a college degree is acceptable.
  • Established working knowledge of current Good Manufacturing Practices and other applicable regulations.
  • Experience with electronic document management systems management (EDMS)
  • Experience working with Quality Management Systems (QMS)
  • Previous experience with regulatory audits (i.e., FDA).