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Quality Assurance Manager

Location: Morristown
Posted on: May 14, 2022

Job Description:

General Summary: The Manager, Quality Assurance will be responsible for planning, developing, and implementing processes and procedures for controlling and maintaining the required level of quality for the product supplied by the organizational unit. He/she will be responsible for reviewing product performance, coordinating with internal manufacturing, supply, and regulatory groups as well as external vendors to meet established quality objectives and to proactively identify and resolve quality problems that may arise. The position reports to the Executive Director, Regulatory Affairs and Quality Assurance. Job Responsibilities: Responsible for collaborating with regulatory and supply functions to ensure all production processes comply with cGxPs and regulatory requirements. Oversee the establishment of qualifications and validations of new and existing products and procedures. Provide QA oversight, review and approval of GxP deviations, investigations, product complaints, CAPAs and change control systems associated with product(s). Support regulatory inspections for deviations, product complaints, CAPAs, change control systems. Conduct GMP audits of suppliers, CMOs and vendors and prepare written reports. Continually evaluate quality system supporting GMP manufacturing operations for potential improvements. Generate and evaluate trend reports and metrics to measure key quality attributes in manufacturing operations. Work with CMOs and suppliers to effectively resolve deviations and out of specification results and oversee investigations and corrective actions. Actively participate in batch record review. Participate in internal audit program. Ensure corrective and preventative actions are implemented and effective. Provide reports and/or updates as they relate to quality activities and completion of projects. Review and approve test procedures, validation procedures, artwork changes, etc. Other duties as assigned by the Exec. Director of Regulatory Affairs and Quality Assurance. Minimum qualification: -- Bachelor---s degree in science or related life sciences field. -- Must have 5 plus years--- experience in a quality position. -- Vaccinated for COVID-19 and the ability to show proof of an FDA-authorized COVID-19 vaccination Other Job Specific Skills: -- A thorough knowledge of cGMP, GLP, and principles of QA/QC. -- Strong knowledge of FDA quality systems regulations, qualifications, and validation requirements. -- Experience in writing reports and compilation of documents required for regulatory submissions. -- Detail oriented and has excellent organizational skills. -- Able to work in a multi-faceted operation. -- Ability to drive projects to completion under pressure. -- Ability to travel to up to 50% of the time (domestic and international) -- Strong interpersonal, communication and technical writing skills. -- Ability to manage and organize time effectively -- Excellent interpersonal, teamwork, leadership, organizational and negotiating skills. -- ASQ Certified Manager of Quality/Organizational Excellence is a plus. -- Familiar with manufacturing techniques, project management and formal continuous process improvement techniques.

Keywords: ASCEND THERAPEUTICS U.S., LLC, Newark , Quality Assurance Manager, Executive , Morristown, New Jersey

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