ZL02-091823 Specialist Quality Complaints
Encontrado en: Talent PR C2 - hace 6 días
START YOUR APPLICATION
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Specialist Quality ComplaintsPrimary responsibilities include: Supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
Qualifications:
Science or Engineering degree: Doctorate degree or Master's degree and 3 years of directly related experience to the job or Bachelor's degree and 5 years of directly related experience to the job or Associate’s degree and 10 years of directly related experience to the job Experience with: investigations Root Cause Analysis Complaint investigations 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully manage workload to timeliness Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes) Ensures quality of complaint records, consolidated / trend investigations Facilitate cross-functional meetings to plan and coordinate the plan for closure of records Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information Executes against prioritized work plans Quickly escalates issues that cold impede the ability to close records according to action plans Maintains compliance with local and global processes Follows procedures and regulatory requirements Reviewing and acknowledging information contained in product complaint records Determining if additional information is required to assign appropriate investigation requirements Determining if return samples are required and following its status Reviewing and approving assessments supporting the investigation Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event Completing historical data analysis and trend evaluation assessments Voiding records if required Completing customer feedback records if required Own consolidated/trend investigations until closure, if required Software: Trackwise, Excel, Word, Microsoft office. Must be fully bilingual (English / Spanish) with excellent oral skills. Available to work extended hours, possibility of weekends and holidays. START YOUR APPLICATION-
Specialist Quality Complaints
Encontrado en: Talent PR C2 - hace 6 días
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Encontrado en: Talent PR C2 - hace 6 días
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Specialist Quality Complaints
Encontrado en: Talent PR C2 - hace 5 días
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Specialist Quality Complaints
Encontrado en: Talent PR C2 - hace 6 días
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Encontrado en: Talent PR C2 - hace 5 días
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Encontrado en: Talent PR C2 - hace 5 días
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