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Quality Assurance Specialist

Company: Raybow USA, Inc.
Location: Durham
Posted on: November 19, 2021

Job Description:

Job Location: Brevard, NC (on-site only)Raybow USA is the US headquarters for Raybow Pharmaceuticals, a global CDMO.A quality assurance (QA) specialist's primary duty is to support the quality function by overseeing GMP activities, documentation and reports.This is a permanent, full time position located in Brevard, NC.Requirements - Quality Assurance Specialist

  • Bachelors degree preferred
  • 2-5 years of experience with Bachelor's degree OR
  • 5+ years experience or demonstrated excellence in role with justification
  • 1 year experience pharmaceutical, GMP or other regulated industryResponsibilities and Duties - Quality Assurance Specialist
    • Support internal, client, and/or regulatory audits
    • Review and approve SOPs, protocols and analytical methods for compliance
    • Execute assigned quality tasks (pre-approving instructions, reviewing documentation of executed instructions and production batch records, reporting metrics, document drafting)
    • Review and approval of document change requests
    • Provide direction for and reviewing and approving deviations, corrective and preventive actions, and risk assessments
    • Review resolution and effectiveness of corrective actions and audit responses.Benefits Package
      • Health/Dental/Vision/Long-term Disability
      • Vacation
      • Matching 401K Retirement Program
      • Relocation PackagePLEASE PROVIDE RESUME IN WORD OR PDF FORMAT AND STATE CITIZENSHIP/VISA STATUS CLEARLY. WE DO NOT SPONSOR VISA APPLICATIONS.Raybow USA is the US headquarters for Raybow Pharmaceuticals, a global CDMO. We conduct contract research and development in organic and medicinal chemistry in addition to our own proprietary research. We also provide custom synthesis of CTM API's (Active Pharmaceutical Ingredients for use in Clinical Trials) manufactured under cGMP conditions.Raybow USA currently has 26 employees working in an 11,400 sq. ft. facility built on 3.5 acres. We are located in Transylvania County in Western North Carolina. This mountain county is well known for providing outdoor recreational attractions (60% of the county is state and national forest), an excellent school system and an excellent quality of life.Job Type: Full-timeBenefits:
        • 401(k) matching
        • Dental insurance
        • Health insurance
        • Life insurance
        • Paid time off
        • Relocation assistance
        • Vision insuranceSchedule:
          • 8 hour shift
          • Monday to FridaySupplemental Pay:
            • Bonus payCOVID-19 considerations:Masks and temperature checks required.Application Question(s):
              • If offered a position, are you willing to move to Brevard, NC?Experience:
                • Pharmaceutical QA: 2 years (Preferred)Language:
                  • fluent english (Preferred)Work Location:
                    • One locationWork Remotely:
                      • NoWork Location: One location

Keywords: Raybow USA, Inc., Durham , Quality Assurance Specialist, Other , Durham, North Carolina

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