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Quality Assurance Analyst at Cognizance Technologies
St. Louis, MO 63045, USA -
Full Time

Start Date

Immediate

Expiry Date

06 Dec, 25

Salary

90000.0

Posted On

07 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description
Responsibilities
  • Lead and maintain the Quality Management System (QMS) in accordance with ISO 17025 standards.
  • Support and manage quality documentation using MasterControl (QMIS).
  • Conduct software validation and documentation review.
  • Perform root cause investigations and implement CAPAs (Corrective and Preventive Actions).
  • Develop and maintain internal quality procedures (IQPs) and Quality Implementation Plans (QIPs).
  • Work with FDA staff and stakeholders to improve systems and ensure compliance.
  • Support audit readiness, reporting, and process improvements.
  • Produce monthly progress reports and maintain FDA-required records.