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Job #02840

About our client Our client is a leading drug company with close to $10B in sales and over 10,000 employees worldwide. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Quality Specialist San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate independently in cross-functional teams providing GCP/GLP guidance and risk-based options during meetings 2) Review study documents (e.g. protocols, system validation reports and final study reports) 3) Check document for consistency and acceptable standards and practices 4) Collaborate and facilitate meetings independently with specific functional groups providing guidance on SOPs (i.e. content, quality, SOP lifecycle, etc.) 5) Identify gaps and address any documentation need 6) Conduct process-mapping sessions and suggest process improvements 7) Participate independently in developmental initiatives (cross-functional teams), applying in-depth knowledge of internal processes, procedures and regulations 8) Lead projects assigned by the management team (independently) 9) Develop appropriate assessment tools 10) Plan, schedule and conduct assessments 11) Report trends and analyze data findings 12) Provide support during regulatory inspections and internal functional group audits 13) Review documents for good documentation practices 14) Advise junior staff in the areas of regulations and documentation as well as meeting facilitation Requirements 1) Bachelor’s degree or equivalent in scientific or quality-related field (or equivalent combination of education, training and experience) 2) 7+ years of GCP/GLP quality experience in a pharmaceutical/biotech company with minimum 4 years in QA 3) In-depth understanding and knowledge of drug development, study designing, data and trials management systems, procedures as well as documentation practices 4) Knowledge of Electronic Document Management Systems (EDMS) in performing all EDMS activities related to SOPs 5) Good understanding and application of developmental SOPs, departmental controlled documents, GCPs and regulations 6) Superb knowledge of GCP/GLP regulations 7) Good understanding of documents governing inspection readiness