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Job #03368

About our client Our client is an established CRO that is a leading resource for contract semi-solid and liquid development, manufacturing and packaging services. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Manager California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide quality assurance management for sterile operations 2) Oversee all quality requirements for the sterile operations area including raw material, in process and FP controls 3) Train and allocate resources for quality support of sterile operations 4) Manage and allocate quality resources and staff for the sterile operations 5) Establish SOPs for sterile operations 6) Support audits by external parties (as needed) and conduct internal audits 7) Oversee maintenance and adherence to established quality systems including change control 8) Conduct and support investigations 9) Manage quality assurance inspections 10) Ensure compliance with cGMP for aseptic manufacturing 11) Maintain an understanding of and comply with all company safety, environmental and quality practices and procedures as well as federal, state and local regulations Requirements 1) Degree (4 year) 2) 4 years of management/supervisory experience 3) Experience in a sterile manufacturing facility 4) Strong GMP experience 5) Knowledge of sterilization theory and equipment 6) Ability to organize and prioritize work in order to accomplish tasks assigned