Quality Assurance Associate

4 weeks ago

Huntsville, United States MyKelly Full time
Kelly Science & Clinical is seeking a Quality Assurance Associate in Huntsville, AL.

Contract Position - 3 months
Shift: Monday - Friday 8am-5pm
Compensation: based on experience 

Responsibilities:
  • Support quality initiatives and be an advocate for quality throughout the company
  • Maintain electronic Quality Management System
  • Respond to daily quality issues including representing Quality in various meetings
  • Assist in leading initiatives and maintaining quality systems in accordance with applicable regulatory standards (i.e., ISO, CAP/CLIA, GxP)
  • Assist in preparation for and hosting client audits and annual ISO, CAP/CLIA, GxP surveillance audits
  • Collaborate with colleagues to audit, identify and correct quality issues and improve internal processes
  • Develop procedures, job-aids and other controlled documents
  • Perform trend reporting of non-conformances, supplier issues and customer complaints etc. to track KPIs and flag quality concerns to be presented to department managers and executives
  • Review and support investigations/CAPAs of non-conformances, supplier issues and customer complaints and recommend corrective actions
  • Conduct Internal Audits
  • Support to departments during implementation of quality tasks
  • Assist in validation studies
  • Educate employees on Quality Management System through training and presentations
  • Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts
  • Ensure compliance with all laws and regulations applicable to the Company and its operations
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Consistent and predictable attendance is an essential function of the position.
Qualifications:
  • At least two years’ professional work experience, preferably in the Quality Management field
  • Previous biotech or medical experience preferred
  • Experience supporting a Genomics business is preferred
  • Experience with internal and external audit processes preferred
  • Excellent computer skills, including Microsoft Excel, Word and PowerPoint
  • Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
  • Able to work independently as well as in an in-person and virtual team setting
  • Ability to motivate and lead others through changes
  • Excellent English verbal and written communication skills
Education Requirements:
  • Bachelor’s degree preferred, with major in life sciences 
  • Apprenticeship in natural science
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