3 qa specialist jobs found

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. In this role, a typical day may include: L eads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation...

We are currently looking to fill a Manager, Process Validation Oversight position. This leads a department responsible for the oversight of qualification of the equipment, systems, and processes validation for our Contract Manufacturing Organizations (CMOs) and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.   In this role, a typical day may include: ·          Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. ·          Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff.  Based on engineering specification, performs validation projects which include authoring...

We are currently looking to fill a Manager, QA (Supplier Quality) position. This position coordinates the Quality Assurance initiatives for a broad range of topics relative to material and supplier quality including Supplier Management and Material Qualification. This role also supervises a team of Material Supplier and Compliance Specialists.   In this role, a typical day might include the following: ·        Accomplishes material and supplier quality objectives through team members and by planning and evaluating area activities. ·        Track status of quality records including document workflows (SOPs, material specifications, etc.), change controls, deviations, CAPAs, extensions, and SCARs. ·        Defines and implements quality standards, systems, and metrics for clinical and commercial operations. ·        Preparing and completing action plans while implementing productivity and quality. ·        Resolving problems,...