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GCP QA Specialist IIIGenentech - South San Francisco, CAJob Description: -Independently participate in cross-functional teams specifically Protocol Execution Teams providing GCP guidance on documentation, study management, and oversight of contracted services -Review study documents (e.g. protocols, Informed Consent, Investigational Brochure) for consistency and acceptable standards and practices. Assure functional groups understand the review comments and capable of implementing the recommendations. -Solid understanding and application of Development SOPs, departmental controlled documents, Code of Federal Regulations and ICH guidelines relevant to Good Clinical Practices -Independently collaborates and facilitates meetings with specific functional groups providing guidance on SOPs (i.e. content, quality, SOP lifecycle), identifying gaps, addressing...originally from Nature.com - More Tools...
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