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Associate Director, Quality Assurance

Company: Ascent
Location: Mountain View
Posted on: November 11, 2019

Job Description:

?Associate Director of Quality Assurance (Consultant)Mountain View, CATHE POSITIONThe incumbent will have a key role via direct interaction with global development partners and regulatory and quality consultants. This role offers an exciting opportunity for a talented professional to contribute significant breadth and depth of their quality control expertise as well as develop significant career experience in the emerging field of regenerative medicine. The incumbent in this position will be responsible to contribute to the Company's programs and success as follows:PRIMARY POSITION RESPONSIBILITIES

  • Qualification and oversight of outside testing contractors.
  • Review and acceptance of test results and raw data received from Contract Manufacturer Organizations (CMO) and Contract Testing Laborites (CTL) to enable lot disposition. Technical review and approval of deviations, investigations and Out-of-Specification results.
  • Establish, manage and report on stability programs for critical reagents used in manufacturing, key intermediates and final cellular products.
  • Transfer of assays to CTLs.
  • Reviews and approvals of method validation protocols and reports.
  • Participate in audits of CMOs and CTLs.
  • Write and review CMC regulatory sections. QUALIFICATIONS & KEY ATTRIBUTES:
    • Degree in scientific/related field (preferably cell biology) plus 5+ years of QC experience in biopharmaceutical environment.
    • Prior experience in interaction with FDA reviewers/inspectors and pre-submission meetings.
    • Working knowledge of global regulations and standards including FDA ISO, EMA, Canadian and JPAL.
    • Experience in a virtual company overseeing with Contact Manufacturing Organizations and Contract Testing Laboratories.
    • Experience in method development, method optimization and method validation.
    • Excellent technical writing skills.
    • Knowledge and experience with raw material testing, release, and data review.
    • Attention to detail and good documentation practices, and proofreading skills with logical stepwise problem-solving ability.
    • Strong problem solving, risk assessment and impact analysis abilities.
    • Well organized with the ability to multitask in a fast-paced environment. Proficiency with MS Office applications required.

      Company Description:

      About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, San Francisco , Associate Director, Quality Assurance, Executive , Mountain View, California

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