• Manager, Quality Assurance

    AMRIAlbany, NY 12260

    Job #1176464926

  • Title: Manager, Quality Assurance Location: US-NY-Albany Job Number: 1003481

    MANAGER, QUALITY ASSURANCE in Albany, NY AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Manager, Quality Assurance is an integral part of the AMRI team, contributing to our success by ensuring site compliance with applicable cGMP regulations including, but not limited to, overseeing the management of the site quality systems (i.e. change management, deviations, investigations, CAPAs, complaints) and ensuring that the principles of data integrity are consistently implemented at the site. The Manager, QA will ensure implementation of AMRI quality policies and standards and will drive continuous improvement activities based on the evolving regulatory requirements and industry best practices. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. In this role, you will: · Assist the Director, QA with the development, implementation, and strict adherence to a quality assurance program. Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials. · Oversee the disposition of GMP materials. Oversee and assist with the site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications. Make recommendations regarding facilities, equipment, personnel, procedures, and systems to carry out the quality function. · Ensure that the data integrity principles are understood and implemented consistently throughout the site. · Responsible for customer on-site audits including the management of audit responses and CAPA plans. · Review and manage customer quality agreements in accordance with company standards. · Prepare and review quality complaint trends. Report serious or repeated failures or unreliability in quality of materials and/or services. Recommend corrective actions or plans/programs for overall defect reductions. Recommend and implement methods to increase the quality of materials and/or services. · Collect, monitor and report quality metrics identifying and leading opportunity for improvements to achieve and maintain high quality standards and ensure customer satisfaction. · Assist Director, QA during inspections by regulatory authorities. Implement inspection-readiness programs and ensure that proper CAPAs are prepared and completed on time. · Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide while achieving the site business goals. This includes also leading and supporting site-wide cGMP training activities. · Effectively communicate with internal and external customers making sure that the AMRI values and business goals are consistently achieved. SUPERVISORY RESPONSIBILITIES · This position will have supervisory responsibilities. Qualifications: Education and/or Experience: B.S./B.A. or M.S. degree in Chemistry or related field. At least five years of experience in the pharmaceutical industry in drug substance or drug product manufacturing, with at least 3 of those years being experience in Quality Assurance. Professional background not directly working in a QA function will also be considered given a relevant technical background and understanding of cGMP requirements. Strong knowledge of the pharmaceutical industry regulations applicable to API manufacturers, including FDA regulations. Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal. Strategic and critical thinking skills. Strong communication skills. All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply. Other Locations:

    EOE Protected Veterans/Disability

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