Sr Quality Document Control Specialist

Sr Quality Document Control Specialist, San Francisco, CA

Contract to Hire

RESPONSIBILITIES:

  • Strong understanding of Quality Management processes and documentation in the following areas:
    • Audit reports
    • Master audit schedule
    • Observation and response documents
    • Vendor Qualification and Management
    • Audit Management
    • Deviation
    • Investigation
    • CAPAs
    • Change Control
  • Maintain Quality System controlled logs and/or project management tools abreast and accurate.
  • Track and trend Quality System documents (i.e., deviation, CAPA, change control, internal/external audits, etc.) to support the reporting of QA KPI metrics.
  • Monitor and follow up with external and internal stakeholders for outstanding Quality System documents to ensure timely closure.
  • Compile Quality System documents (both electronic and hardcopy) for archival.
  • Support the implementation and maintenance of relevant electronic quality management systems (e.g. execute test scripts per protocols, etc.).
  • Working knowledge of relevant regulations and guidances.
  • Demonstrated organizational skills that have proven results in the ability to be self- directed while managing multiple projects.
  • Sound judgement and resolution proposing abilities.
  • Proficient in communication (written and verbal).
  • Strong flexibility and strong ability to multitask across multiple functional areas.
  • Timeline focused and flexible in their work scheduling to meet the demands of a multi- product early development programs.
  • Other responsibilities as needed.

 

QUALIFICATIONS AND EXPERIENCE:

  • Prefer a bachelor’s degree in Molecular and Cellular Biology, Biochemistry, Microbiology, 5 or more years of experience – OR – an equivalent combination of education and  experience in QA.
  • Works well under pressure with an ability to meet tight deadlines
  • Highly proficient in Microsoft Office, especially MS Excel

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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