Senior Quality Assurance Specialist – Mountain View

Categories: Inspectors & Testers, Medical Product Technician, Pharmaceutical, Production Support, Science/Biotech TechniciansThis Company located in Mountain View, CA, 25 miles from the San Francisco Bay Area, is a product based biopharmaceutical business focused on developing novel treatments for respiratory and CNS diseases. The principal product development strategy is to create innovative therapies with large market potential to improve safety, efficacy, and patient compliance. The Companys main focus is on the patient and in developing therapies that provide convenient and differentiated patient benefits. Faster onset of action, less invasive delivery (as compared to needle injection) and treatment at the lowest effective dose as well as improved clinical results are all benefits this company is targeting for the therapies they have under development. They are building the company on this basis by surrounding themselves with exceptionally focused, diligent, and experienced colleagues. They strive in creating an environment where teamwork, integrity, and accomplishment are valued. Currently seeking a Senior Quality Assurance SpecialistFunctionResponsible for evaluating the compliance of manufacturing, clinical and preclinical activities conducted by the Company to US FDA regulations, OECD and ICH guidelines, as well as corporate policies and standard operating procedures. Specific Responsibilities and Activities 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. 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. 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. Review and generate Protocols, SOPs, Batch Records, Case Reports, Data Reports, Interim Reports and Final Reports. Interact effectively with other company employees within a team setting by providing technical solutions to a wide range of difficult compliance problems and complexity. Other duties as assigned. Requirements:RequirementsEducation BS in biological or life sciences, or equivalent with 5+ years of experience working in a GCP (performing audits on clinical sites) environment.Other The ability to travel up to 40% of time, both domestic and international. Excellent communication skills, both verbal and written.

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Salary: Competitive