Quality Assurance Specialist

2 weeks ago


Salt Lake City UT United States Integrated Resources, Inc ( IRI ) Full time

Title: Quality Analyst III

Location: Salt Lake City, UT

Duration: 6 months (Temp to Perm: No)

Shift Schedule: Monday - Friday 8:00am - 5:00pm

Job Description:

  • Performing QA review/approval of investigation reports, change controls, Standard Operating Procedures, investigation documentation, and process/facility change control documents.
  • Manage and track tasks for assigned Quality projects, CAPAs, and/or Audit Response commitments, and other initiatives to assure on time completion.
  • Responsible for collaborating with appropriate departments to resolve both technical and compliance issues by providing Quality Assurance oversight.

Education/Certification/Experience:

  • Bachelor's degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 10 years relevant progressive experience in the pharmaceutical industry.
  • Requires a minimum of 3 years of experience in Quality Assurance, Quality Engineering, or Compliance role within pharmaceutical industry.

Skills/Knowledge/Abilities:

  • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise.

Core Skills:

  • Performed QA review/approval of non-complex investigation reports, change controls, Standard Operating Procedures.
  • Support investigations using root cause analysis tools.
  • Manage and track tasks for assigned Quality projects, CAPAs, and/or Audit Response commitments.


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