Quality Assurance Specialist

Overland Park, KS Full Time
POSTED ON 3/20/2024

POSITION SUMMARY: As a Quality Assurance Specialist you will review and confirm procedures, track and follow up on commitments and participate in audits and investigations. Tracking Compliance metrics and overseeing vendor qualification and status.

KEY RESPONSIBILITIES:

  • Participates in audits, CAPA’s, and investigations.
  • Performs internal audits and effectiveness checks.
  • Reviews SOP, job aids, and other documents for accuracy and completeness.
  • Evaluate & determine current regulations related to Clinical Research against site SOP’s and processes.
  • Participates in Computer System Validation (CSV) efforts.

REQUIRED QUALIFICATIONS:

  • 3-5 years experience in Quality.
  • Good working knowledge of regulated environments.
  • Trained on cGXP.
  • Excellent communication skills & understanding of SOP/departmental processes.
  • Excellent reporting writing skills & ability to adhere to strict timelines.

PREFERRED QUALIFICATIONS:

  • Experience within a clinic, hospital, pharmaceutical, or similar type environment.
  • Experience responding to audits by sponsors and government agencies.
  • Computer System Validation experience.
  • Experience with MasterControl.
  • Experience with conducting and/or evaluating CAPA’s and investigations.

If you are a detail-oriented individual, enjoys working directly with staff from every department and has a passion for ensuring quality, we would love to hear from you. Apply now to join our team as a Quality Assurance Specialist.

Job Type: Full-time

Benefits:

  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Paid time off
  • Vision insurance

Experience level:

  • 3 years

Schedule:

  • Monday to Friday
  • Weekends as needed

Work setting:

  • In-person
  • Office

Ability to Relocate:

  • Overland Park, KS 66212: Relocate before starting work (Required)

Work Location: In person

Salary.com Estimation for Quality Assurance Specialist in Overland Park, KS
$95,397 to $116,283
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