Onsite Quality Assurance Specialist II

Posted 4 days ago

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About the role

  • Quality Assurance Specialist responsible for quality tasks and operations at Thorne. Managing compliance and supplier relationships while supporting quality assurance processes in a fast-paced environment.

Responsibilities

  • Responsible and accountable for quality tasks and operations.
  • Supports Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process, supplier qualification process, internal audit process and third-party audit process.
  • Schedules, coordinates, and conducts audits of suppliers including, but not limited to, contract manufacturers and raw material suppliers.
  • Works with the Material Review Board, Purchasing, and Suppliers to resolve product issues.
  • Coordinates and manages relationships with outside contract manufacturers.
  • Manages working relationships with all Thorne Research outside manufacturers.
  • Coordinates with contract manufacturers to ensure adequate communication on and understanding of requirements.
  • Builds strong working relationships with purchasing, engineering, quality, planning, and the sales team when dealing with requirements for contract manufacturing and supply chain integrity.
  • Initiates and completes customer complaint investigations. Communicates complaint investigation details, root cause, and CAPAs (when applicable) to appropriate parties.
  • Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.

Requirements

  • Minimum Bachelor’s degree with at least four years of related experience; or equivalent combination of education and experience.
  • Ability to effect change in a positive environment.
  • Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
  • Initiates and completes reports in a timely manner.
  • Works independently with little direction or oversight, in a fast-paced environment.
  • Schedules projects and meets tight deadlines.
  • Ability to travel more than 50% of time.
  • Develops and delivers on assigned objectives within requested timeframes.
  • Possesses good interpersonal skills and engages others in a positive manner.
  • Possesses strong attention to detail.
  • Possesses strong verbal and written communication skills.
  • Raises issues and concerns promptly and offers pragmatic solutions for consideration.
  • Documents and presents work in a clear, accurate, and concise manner.

Benefits

  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • Company-paid short- and long-term disability insurance
  • Company-paid life insurance
  • 401k plan with employer matching contributions up to 4%
  • Gym membership reimbursement
  • Monthly allowance of Thorne supplements
  • Paid time off, volunteer time off and holiday leave
  • Training, professional development, and career growth opportunities
  • A safe and clean work environment

Job title

Quality Assurance Specialist II

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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