KSL Biomedical Careers

Quality Assurance Specialist

US Diagnostics Sales Representative
USA Office - Buffalo, NY 14221
Full-time, $20-$25/hour


Job Purpose / Summary:


​This position will help ensure the set standards are achieved and provide support in maintaining the quality management system. This position is responsible for assisting the Corporate Quality Manager in managing the Quality System. 

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Duties and Responsibilities:

  • Write and where needed, manage documents to support the management function for Quality, CAP, NYSDOH, CFR and ISO.

  • Support customer complaints and nonconforming material process to ensure root cause analysis, timely response, and implementation of corrective actions.

  • Work with suppliers to ensure conformance through document process monitoring 

  • Maintaining calibration and maintenance of equipment, working with suppliers to establish services, when required 

  • Manage equipment and process validations 

  • Manage assigning and monitoring training of personnel

  • Assist in the development and monitoring of Corrective and Preventive Actions

  • Assist in the ongoing compliance with the quality system and industry regulatory requirements

  • Participate in internal, supplier and external audits

Requirements:

  • Education, skills and / or work experience requirements:

    • In-Depth knowledge of cGMP and quality systems

    • High School Diploma or higher

    • Problem solving skills and troubleshooting abilities

    • Detail orientated and good time management skills

    • Communicate both written and orally to personnel at all levels of the organization

    • Experience with the implementation of a quality management system

    • 5 years experience with cGMP and or CLIA Laboratory QMS, minimum

    • Internal auditing experience

    • Proficient in the use of computers, especially windows based systems and Microsoft office applications. 

    • Proficient in Excel to utilize analytical tools to create charts, pivot tables etc to better analyze and evaluate information

Physical requirements:

  • Able to sit or stand 50% of the time