Available Positions

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

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

Job ID: 62295

Job Description

INDIVIDUAL RESPONSIBILITIES:

  • Review and processing of change controls
  • Review of technical protocols and reports including:
    • Analytical methods validations and method transfers
    • Reference standards protocols and reports
  • Reviewing regulatory dossier sections as well as verification and trending of process data and deviations

 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • These may include but are not limited to:
    • Develop and execute change control implementation plans
    • Verify and reference rHuPH20 Dossiers
    • Review and edit Standard Operating Procedures
    • Review technical and stability reports as well as protocols
    • Execute Batch and Formulation Records
    • Perform Quality Assurance activities associated with the maintenance of other internal Quality Systems such as: deviation trending and CAPA system
    • Perform Quality Assurance review and/or document audits on Client or contractor documents

Qualifications

TECHNICAL KNOWLEDGE REQUIRED:

  • Equipment:  PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
  • Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: EDS, Veeva QualityDocs (preferred)

INTERNAL AND EXTERNAL RELATIONSHIPS:

    • Maintain productive relationship and open communication with Regulatory, Manufacturing, Product Development, Research and Development, Project Teams, and Clinical Research/Operations
    • Maintain productive and cooperative relationship with partners and contract manufacturing, test organizations, and other contract service providers as required
    • Interface with Client QC, Manufacturing, Supply Operations, Product Development, Regulatory Affairs, and other departments in support of Client’s goals and initiatives

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