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Quality Assurance Compliance Officer

Company name
The General Hospital Corporation

Boston, MA

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Description The Quality Assurance Compliance Officer willperform chemical analysis and synthesis support of radiopharmaceuticals forPositron Emission Tomography (PET) products in a GMP environment.\u00a0The individual should be capable ofindependent analytical and decision-making abilities and will be also calledupon to troubleshoot analytical and manufacturing issues. The Quality Assurance Compliance Officer is primarilyresponsible for promoting compliance and a continuous improvement culture todrive process and cost improvement. Plan, organize, implement and support teamcentered continuous improvement activities. Responsible for the identification& resolution of non-value added activities, development of cost reductionprojects utilizing root cause corrective action and process maps for effectiveproblem solving. PRINCIPAL DUTIES AND RESPONSIBILITIES:\u00a0 \u00b7Operates, maintainsand calibrates automated and semi-automated radiopharmaceutical manufacturingequipment. \u00b7Oversee productionand quality control. Lead, organize and train team members on the technological transfer of production processes (synthesis) and analytical methods Lead and execute the qualification of analytical equipment, the validation protocols and the analytical methods validation. Prepare SOPs, validation protocols and validation\/qualification reports Contribute to the production of PET tracers and industrialization of the new synthesis processes. Contribute to the quality control of PET tracers Initiate and author Investigations, CAPAs, Deviation and Change Control documentation as related to manufacturing and testing of radiopharmaceuticals.\u00a0 \u00b7Followand observe all radiation safety procedures in agreement with the ALARAprinciple. \u00b7Providerelated training to other staff members as required. Participate to the qualification\/validation campaign for new radiopharmaceuticals implementation according to GMP standards.\u00a0 Maintain a clean and safe working environment in compliance with safety and pharmaceutical regulation.\u00a0 Perform radiation safety duties in compliance with regulations. Efficiently comply with waste management rules and regulations. Ability to work various hours depending on daily dose production SKILLS & COMPETENCIES REQUIRED: Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. Of particular importance understands quality systems. Possesses some knowledge of project management tools and has some experience leading cross functional teams. Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others. Able to critically think, assess problems and collaborate to come to an appropriate resolution. Proactive and driver of continuous improvement operations. Applies risk management philosophy to business processes, decisions, and data Innovation- Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Applies risk management philosophy to business processes, decisions, and data To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Qualifications Required: Bachelor's Degree and 3 years of experience in pharmaceutical\/radiopharmaceuticalresearch and\/or development\u00a0 EEO StatementMassachusetts GeneralHospital is an Equal Opportunity Employer. By embracing diverse skills,perspectives and ideas, we choose to lead. Applications from\u00a0protected veteransand individuals with disabilities are strongly encouraged

Company info

The General Hospital Corporation

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