• Project Manager For South SFO , CA

  • - Project management experience is Must.
    Minimum 8 years experience in the functionality of Empower in the pharmaceutical, biotechnology, or other related industry or minimum of 4 years experience in Empower project management .

    - Experience in NuGenesis SDMS administration/Project management  (minimum of 3 years experience) and familiarity of Labware LIMS projects preferred.

    - Experience in Quality Control laboratory environment preferred

    - Experience with full software development life cycle including requirement analysis, design, implementation, test, documentation and post deployment support.

    - Experience defending computer system validation package in front of auditors (external/internal)

    - Strong analytical, problem-solving and technical skills to develop practical solutions to business problems.

    - Good working knowledge of laboratory testing processes and automation using various instrument software packages.
    Maintain metrics for Empower system usage, user issue logs and system up time across the client sites.

    - Facilitate Empower quarterly release management planning meetings.

    - Contribute to the support and maintenance of validation package as it pertains to Empower: URS, FRS, SDS, TM, and report specifications.

    - Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), and other regulatory requirements or policies.

    - Excellent verbal and written communication skills. Ability to work successfully independently and as part of a group.

    - Ability to communicate effectively across the groups.
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