.The **Clinical Supplies Complaint Coordinator** performs disposition assessment of reported clinical supply temperature excursions that occur at clinical sites globally. The position interacts directly with clinical sites to obtain complete temperature excursion data and provides the disposition of the impacted clinical supplies to the sites.The role is critical in the clinical supplies chain; timely evaluation, stability assessment and proving disposition of the impacted clinical supplies to sites are essential in maintaining availability of clinical supplies at sites without disruption.The role works closely with Global Clinical Supplies,the Global GCD Clinical Supplies Lead SME and several roles in Quality and Continuous Improvement (QCI).In collaboration with QCI, the role may trigger GCP clinical supplies investigations for Country Operations to complete.**Primary Responsibilities**- GCP clinical supplies complaint intake, evaluation, product impact assessment and disposition of clinical finished good supplies impacted by temperature excursion- Manage GCP clinical supplies complaints in centralized system and ensure complete documentation- Coordinate and/or support the preparation of procedures, processes, and quality improvement activities.- Initiate GCP clinical supplies investigations for GCTO Country Ops to complete- Provide support for metrics compilation that are presented at various governance councils.**Education Minimum Requirement**- High School Diploma Required- Bachelor's Degree Preferred, technical emphasis in an appropriate scientific or engineering field**Required Experience and Skills**- Minimum of 2 years post-degree experience in the Pharmaceutical or equivalent industry -in Good Clinical Practices (GCP) or Good Manufacturing Practice (GMP) related field, including Technical,Engineering, Quality or Operations.- Effectiveness and creativity in approaching and solving technical problems.- Evidence of leadership skills coupled with highly developed oral and written communication skills, effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.- Demonstrated teamwork skills and the ability to work independently.- Attention to detail, flexibility and an awareness of production and quality control problems.- Ability to adapt in changing working environment.**Preferred Experience and Skills**- Familiarity with complaints and/or batch disposition (release) activities is a strongly preferred skill necessary for success in this position- Previous experience in quality control, quality assurance,auditing or regulatory affairs.- Ability to independently manage multiple priorities and projects.- Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.- Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management. El anuncio original lo puedes encontrar en Kit Empleo:Https://www
