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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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 Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. 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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