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Job Announcement: Documentation Specialist (CONTRACTOR), SSF, Genentech

  • 1.  Job Announcement: Documentation Specialist (CONTRACTOR), SSF, Genentech

    Posted 01-07-2022 12:18
    You can find this position on the Genentech job site. The team is great to work with. There is a lot of work in the documentation area, because we are responsible for official documents. I am also a contractor at Genentech and feel well treated and well paid. PROUnlimited is the organization that employs all the contractors at Genentech and they have been great to work with.

    SummaryThe Documentation Specialist will be a member of the PTD South San Francisco Device & Packaging Development 'Business Operations Group'. This group plays a key role in connecting people, processes and systems, to enable compliant and agile team execution. This group is responsible for the following: Records Management, Business Excellence, Digital Systems, Knowledge Management, Project Management, Quality System Implementation, and Staffing to sustain a quality mindset and compliance that enables for filing and inspection-readiness. 

    Responsibilities: The Documentation Specialist would be responsible for Quality System Implementation, Document Processing & Records Management.  This role requires the ability to work in an organized manner, while preparing, formatting, scanning, uploading, and checking GMP Records. This role will also involve ongoing electronic document management including document quality checks as well as data entry and uploading into an electronic system (EDMS).


    Other responsibilities for this role include but are not limited to the following:

    • Document Processing & Records Management Support

    • EDMS Support

    • Staff Qualification Documentation Support

    • Project Management of Quality System documentation creation or revision or implementation

    • Records inventory management

    • Records Periodic Review management

    • Records clean up event management

    • Audit/Inspection backroom support


    Skills: Skills Must have the ability to take initiative and work with little supervision. High level of professionalism and the ability to interact with personnel at all levels. High degree of skill and comfort with computer applications and systems. Demonstrate ability to work accurately, follow instructions, and handle multiple priorities. Very strong organizational and communication skills.


    Job Qualifications

    • Bachelor's Degree preferred

    • Strong computer skills (MS Word, Excel and PowerPoint, Adobe Acrobat Pro, gSuite) required

    • Experience with electronic documentation systems (EDMS) required

    • Experience in pharmaceutical/biotech, medical device and device combination products or other GMP-regulated industry preferred.

    • Knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to medical device development and device combination products records preferred

    • Ability to read and understand SOPs and process instructions

    • Must be detail-oriented with strong organizational skills

    • Strong interpersonal skills, verbal and written communications in English

    This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech

    Jaye Lapachet
    (650) 892-8050
    SF Bay Area Community Past President, 2022
    SF Bay Area Community President, 2021
    SF Bay Area Board Member 2021-2022
    Competencies Task Force Member 2017
    SF Bay Region Board Member 2014-2016