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MAP Pharmaceuticals, Inc.

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Position/Title: Senior Quality Assurance Specialist

Reports to: Sr. Manager of Quality Systems

  1. Function
    Responsible for evaluating the compliance of manufacturing, clinical and preclinical activities conducted by MAP Pharmaceuticals to US FDA regulations, OECD and ICH guidelines, as well as corporate policies and standard operating procedures.
  2. Specific Responsibilities and Activities
    1. Support the Clinical Department in conducting its clinical trials under FDA Good Clinical Practices regulations and ICH guidelines, through internal review and external audits. Documents audit observations and make recommendations for corrective action.
    2. Support the Preclinical and Research & Development Departments in its development, validation and toxicological studies under the FDA Good Laboratory Practices regulations and OECD guidelines, through internal review and external audits. Documents audit observations and make recommendations for corrective action.
    3. Support the Manufacturing Department in its development studies, validation and scale-up processes under the FDA Good Manufacturing Practices regulations, through internal review and external audits. Documents audit observations and makes recommendations for corrective action.
    4. Review and generate Protocols, SOPs, Batch Records, Case Reports, Data Reports, Interim Reports and Final Reports.
    5. Interact effectively with other MAP employees within a team setting by providing technical solutions to a wide range of difficult compliance problems and complexity.
    6. Other duties as assigned.
  3. Requirements
    1. Education
      • BS in biological or life sciences, or equivalent with 5+ years of experience working in a GCP (performing audits on clinical sites) environment.
    2. Other
      • The ability to travel up to 40% of time, both domestic and international.
      • Excellent communication skills, both verbal and written.

Send resume to:

Career Opportunities
MAP Pharmaceuticals, Inc.
2400 Bayshore Parkway, Suite 200
Mountain View, CA 94043
Or e-mail resume to: hr@mappharma.com
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