Process Validation

1 week ago

Fremont, California, United States inSync Staffing Full time

Pay rate: $35.71/hr
Hours: Mon-Fri, 8:00AM-5:00PM
Location: Fremont, CA
Duration: 7 months

Summary:
Candidate will work with MSAT Process Validation group with the following responsibilities:

  • Responsible for performing data mapping of Continued Process Verification (CPV) software.
  • Assist in the development and implementation of CPV data mapping strategies.
  • Collect, organize, and map process data and QC data from various sources to ensure accurate and comprehensive data sets.
  • Perform CPV evaluation and generate CPV reports.
  • Generate new work instruction and curriculum to implement new CPV software.
  • Maintain accurate and up-to-date documentation of CPV activities and data mappings.
  • Support other process validation projects (as needed) to ensure processes are validated to required standards.
  • Reviews and interprets data for accuracy for completed validations/re-validations and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
  • Manage all moderate troubleshooting efforts for protocol discrepancies.
    • Basic understanding of GMP (Good Manufacturing Practices) and regulatory guidelines.
    • Proficiency in Microsoft Office including Word, Excel, and Visio.
    • Experience with Minitab or similar statistic analysis software is preferred
    • Process validation background is preferred.
    • Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes is preferred.
    • Excellent technical writing and verbal communication skills
    • Strong analytical and problem-solving skills.
    • Ability to work effectively in a team environment.
    • Demonstrate ability to manage multiple activities while maintaining a high level of organization.
    • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
    Education:
    Required: Bachelor's Degree.

    Benefits (employee contribution):
    • Health insurance
    • Health savings account
    • Dental insurance
    • Vision insurance
    • Flexible spending accounts
    • Life insurance
    • Retirement plan
    All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    #IND03

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