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Quality Assurance Specialist

  • LocationPlano, TX 75024 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 days ago
  • Job no: 39970
  • Category: Quality

Job Description


One of our clients, who specializes in research, is looking for a go-getter to add to their Quality Assurance Specialist Team.


1) Create, maintain, evaluate and implement quality assurance plans and policies for studies conducted at the company’s sites

2) Review and audit of protocols, informed consents, source data, data entry, case reports forms and regulatory documents for accuracy and compliance

3) Provide consistent feedback to study coordinator and managers to ensure compliance

4) Review and audit recruiting documentation

5) Perform in clinic audit of study procedures and study material receipt and return/ destruction to ensure all sites are ready for inspections and audits

6) Assist with documentation of non-conformities, corrective actions, and preventive actions

7) Oversee final review of regulatory and study documents prior to archiving

8) Maintain knowledge of company SOPs to be able to review and ensure SOP compliance

9) Assist with auditing the company training files

10) Assist with training of new departmental staff on SOPs, policies, regulations and guidelines associated with clinical research

11) Work with all involved parties to ensure that both the equipment, lab safety and operational needs are met

12) Encourage prompt reporting of health and safety concerns

13) Perform other duties as assigned


Critical Requirements


1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

2) Recent experience in the research industry is strongly preferred

3) Preference will be given to candidates with recent experience in quality assurance


For the right leader, this role is a fantastic opportunity to be a key player in the exceptional success of this renowned company. If you are qualified and think this could be you, please apply ASAP!


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience

  • Published on 13 Jan 2022, 9:25 AM