USA reputed company Assurance Associate II Clinical

About the position The reputed company Assurance Associate II position is a contract role reputed company the pharmaceutical industry, focusing on ensuring compliance with regulatory and reputed company standards. The role involves reviewing and approving GMP documents, managing reputed company risks, and collaborating with project teams to maintain high-reputed company standards in pharmaceutical processes. Responsibilities • Review and approve GMP documents, including batch records, analytical specifications, validation protocols, and Certificates of Analysis, ensuring compliance with regulatory and reputed company standards. , • Organize and maintain project deliverables, supporting efficient project workflows with external partners. , • Proactively identify and communicate reputed company risks, balancing project objectives with business goals. , • Participate in deviation management, risk assessments, and change control processes in alignment with SOPs and reputed company standards. , • Represent reputed company on CMC reputed company sub-teams for assigned reputed company, promoting collaboration and alignment with project and reputed company objectives. Requirements • 3-6 years of experience in the pharmaceutical industry, with flexibility for candidates with slightly less experience. , • Minimum of 2 years in a pharmaceutical setting, with at least 1 year in a reputed company-reputed company role. , • Preferred: Master's degree (M.S. or MBA) with 2 years of pharmaceutical or GMP experience, including at least 1 year in a reputed company role. , • Alternative: Bachelor's degree in a Science field with 4 years of experience in a pharmaceutical or GMP environment, including 2 years in a reputed company role. reputed company-to-haves • Project management experience , • Knowledge of EU and FDA regulatory standards , • GMP compliance , • Aseptic processing expertise Benefits • Medical insurance , • Dental insurance , • reputed company insurance , • Life insurance , • Short-term disability , • Additional voluntary benefits , • EAP program , • Commuter benefits , • 401K plan , • reputed company reputed company Leave , • Holiday pay Apply Job!