Quality Assurance Specialist

Seeking a senior level QA Specialist for our client – a a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines.

Type: Contract

Location: Jersey City, NJ

Pay: Up to $45.07/hr

Description:

  • Advise Global Pharmacovigilance (PV) teams on change control of procedural documents before work is started to draft revisions.
  • Review change control documents to ensure Global PV business process owners are considering proper training as a part of the procedural changes.
  • Review and approve procedural documents in ETQ to ensure they meet the needs to ensure quality and compliance and strategically move towards a more lean and efficient procedural document framework governing pharmacovigilance and safety surveillance.

Qualifications:

  • Advanced knowledge of end-to-end PV procedural requirements.
  • Ability to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a lean and efficient procedural framework.
  • Mid-level understanding of quality management, change control, and quality management systems.
  • Ability to learn and work in ETQ.
  • Advanced ability to work within fixed timelines and manage a high volume of work/multiple projects at one time.
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