GMP Operational Quality Assurance Manager (Contract) 151515

Job description

Job Description The Quality Manager is a technical resource in the principles and application of quality assurance, quality systems, and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This position reports directly to the GMP Operational Quality Senior Manager. Key Responsibilities: - Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions. - Provide QA support of change controls, investigations, CAPA’s, and effectiveness checks. - Draft, review, and manage approval of quality system documentation, including but not limited to, deviations, change controls, and CAPA’s. - Lead meetings, as necessary, and collaborate with customer groups to ensure quality systems are monitored and established metrics are met. - Perform Batch Record Review of Health Donar and Drug Product lots - Perform Lot Disposition of Critical Components and Drug Product lots - Perform archival activities to support lot disposition - Partner with External...