Available Positions

Quality Assurance Document Auditor at Pharmaceutical Company in San Diego, California, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • San Diego, California, United States
  • 10/11/19

Job ID: 62434

Job Description

POSITION SUMMARY: 

  • The Quality Document Auditor contractor is responsible for providing support to the document audit program by performing Quality document audits on client documents identified as requiring an audit based on their intended use.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • These may include but are not limited to:
    • Perform data verification for client's reports (e.g., non-clinical, analytical, formulation, product development, manufacturing/comparability, stability and clinical research reports) to confirm data/content integrity, report deficiencies as determined by audit, and confirm corrections are carried out
    • Conduct audit of electronic regulatory submissions for content to submit to regulatory agencies
    • Create audit plans
    • Follow relevant SOPs as well as instructions and apply regulatory/compliance guidelines when performing documentation audits
    • Adhere to project timeliness

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

    • Implement and adhere to departmental policies and procedures affecting Quality
    • Other duties as assigned

Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

    • Minimum of a Bachelor of Science degree with at least 5 years of GxP quality assurance experience in the pharmaceutical or biotechnology industry (an equivalent combination of education and experience may be considered)
    • Effective verbal and written communication skills
    • Strong attention to detail with the ability to detect and correct errors/inconsistencies in various type of documents
    • Proven ability to work independently
    • Proven ability to manage multiple projects and meet tight timelines in a dynamic cross functional team environment

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