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QA Specialist

Advanced Cell Diagnostics, Inc.

This is a Full-time position in San Jose, CA posted December 21, 2021.

By joining the Bio-Techne team, you will have an impact on future cutting-edge research.

Bio-Techne and all of its brands provides tools for researchers in Life Sciences and Clinical Diagnostics.  

Position Summary:  

The responsibilities of the Quality Assurance Specialist position are to assist senior quality assurance staff to create an environment that meets the compliance standards of Bio-Techne’s governing bodies. The Quality Assurance Specialist will understand and follow appropriate quality protocols to meet compliance standards.

Key Responsibilities:  

  • Participate in team meetings as a quality representative, assist in management of quality issues and offer input representing quality assurance (new product design, data reviews or root cause investigations) 
  • Work collaboratively with all functions to ensure understanding and conformance with quality requirements
  • Prepares reports and necessary documentation to internal and external stakeholders to include
    • complaint investigations, supplier corrective action requests, corrective and preventative actions
  • Assist and support compliance of the quality systems, by monitoring conformance to appropriate standards and procedures
  • Responsible for monitoring equipment control, supplier management, batch record review and release quality records control, input into management review and other quality system related processes
  • Propose process improvements and areas for improvement to supervisor
  • Follows company policies and practices, understand appropriate lab protocols and follow standard operating procedures (SOPs) including regulatory awareness of chemical handling and hazards, compliance, and proper use of equipment
  • Performs additional duties as assigned

Qualifications

Education and Experience: 

  • An Associate degree with 3-5 years of relevant experience;
  • Or, a Bachelors degree with up to 3 years of relevant experience

Knowledge, Skills, and Abilities:  

  • Attention to detail and organizational skills are required
  • Working knowledge of Microsoft Word and Excel are required
  • Computer entry, typing, or electronic document filing skills are require
  • Must be able to work in a fast-paced environment where multitasking is required 
  • Must have excellent verbal and written communication skills 
  • Knowledge of technical, regulatory, quality and production management systems
  • Knowledge of documentation principles and processes
  • Skills in accuracy, clarity and proofreading
  • Skills in problem solving, identifying root cause and appropriately evaluate a course of actions

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position

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