Quality Assurance Specialist II
9115 Hague Road Indianapolis, IN 46256 US
Job Description
Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Maintains and ensures compliance with quality programs, policies, processes, procedures and that the performance and quality of products conform to established standards, specifications and agency guidelines.
Performs assessment of temperature excursions in supply chain
Performs CAPA assessments
Performs documentation editing
Works with Global Supply Chain Quality Team in US and Europe to ensure quality supply of diagnostics products
Skills
Excellent problem solving, customer service, interpersonal, decision making, communication skills
Knowledge of regulatory quality standards
Excellent organizational, decision-making, human relations and communication skills
Ability to resolve problems in a timely manner
Strong knowledge and understanding of quality, planning, supply chain, inventory management and/or traffic processes and procedures
Education
Bachelors degree in related field
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