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ASD - Quality Assurance Specialist II

Company: Kavaliro
Location: Carlsbad
Posted on: August 3, 2020

Job Description:

RESPONSIBILITIES: Review and approve Quality Records and other cross departmental records from the site. Review Equipment and Validation Records. Work with groups within the organization to get corrections and clarifications to Quality and other Records Prepare labeling for all finished product and perform labeling of product. Responsible for meeting established goals and objectives for the department Utilize Access Database for tracking receipt, review and correction of Batch Records. Utilize JDE to perform transactions and verify product information. Generate Certificate of Conformance/Certificates of Analysis for Final Product. Created specialized Certificate of Conformance/Certificates of Analysis as required. Prepare approved MRPs for filing Responsible review of other documentation (i.e. Facilities) submitted for QA review. Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies. Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships Carries out duties in compliance with established business policies Other duties as assigned, according to the changing needs of the business MINIMUM QUALIFICATIONS - EDUCATION/EXPERIENCE: Minimum education: High School Diploma or equivalent. Minimum experience: 2-4 years related experience. Working knowledge of Quality Assurance in a medical device manufacturing environment. Knowledge of Quality System Regulations. PREFERRED QUALIFICATIONS: Preferred Background: Bachelor's Degree preferred 2 - 4 years of quality assurance knowledge, preferably in in-vitro diagnostics. Experience with MS Office Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor. Must be detail-orientated, self-motivated and available for flexible scheduling. Strong communication, problem solving and motivational skills. Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision. Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment. COMPETENCIES: Actively develops a network to bring best solutions to the team or customer. Role models Quality First by continuously improving on what matters most to customers. Promptly and effectively handles issues and problems. SDL2017

Keywords: Kavaliro, San Diego , ASD - Quality Assurance Specialist II, Other , Carlsbad, California

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