Associate Scientist, Microbiology – Quality & Compliance

Fresenius Kabi USA

Kansas

On-site

USD 32,000 - 45,000

Full time

14 days+
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Benefits offered by this job

401(k) contributions
Paid vacation
Holidays and personal days
Employee assistance program
Medical coverage
Dental coverage
Vision coverage

Job summary

Fresenius Kabi USA seeks a quality assurance professional to oversee quality plans, revise SOPs, support audits and inspections, and lead adoption of new regulations to ensure GCP standards in clinical trial processes.

The role includes an attractive benefits package with medical, dental and vision coverage, a 401(k) with company contributions, paid vacation, holidays and personal days, plus access to an employee assistance program.

Qualifications

  • Experience in quality assurance for clinical trials or regulated environments.
  • Familiarity with Good Clinical Practice (GCP) and regulatory audits.
  • Strong documentation and data integrity skills.

Responsibilities

  • Articulate work related issues clearly to management and peers.
  • Completes testing and documents in compliance with Good Documentation Practices.
  • Maintains accurate records of all work performed.
  • Completes assessment of testing results and reports discrepancies promptly.
  • Documents, investigates, and reports incidents; carries out corrective actions.
  • Manages work and time based on departmental priorities using judgement.
  • Performs good housekeeping practices.
  • Follows safety related policies; makes recommendations.
  • Performs peer review of data to ensure accuracy and compliance.
  • Maintains current training compliance through KabiLift.
  • Assumes additional responsibilities as assigned.

Job description

Fresenius Kabi USA seeks a quality assurance professional to oversee quality plans, revise SOPs, support audits and inspections, and lead adoption of new regulations to ensure GCP standards in clinical trial processes.

The role includes an attractive benefits package with medical, dental and vision coverage, a 401(k) with company contributions, paid vacation, holidays and personal days, plus access to an employee assistance program.

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