Night QA Specialist, CGMP Compliance & Root-Cause

HITEC

Jackson (MS)

On-site

USD 60,000 - 77,000

Full time

2 days ago
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Benefits offered by this job

Medical, dental and vision coverage
Paid time off
401k savings plan
HSA
Paid parental leave

Job summary

Cardinal Health in Mississippi (Jackson) is seeking a Quality Assurance professional to support CGMP compliance, product release, and CAPA management. You will review documentation, perform investigations, and collaborate with cross-functional teams to ensure quality and regulatory alignment.

The role requires 2+ years in a related science field, a bachelor’s degree, ability to lift 50-75 lbs, and up to 20% travel. Night shift with 40 hours/week; salary range provided.

Qualifications

  • Bachelor’s degree in related science field or equivalent work experience.
  • 2+ years of experience in a related science field preferred.
  • 1-2 years of experience in Quality Assurance in a regulated environment (cGMP) preferred.
  • Pharmaceutical or medical device experience a plus.
  • Effective written and verbal English communication skills.
  • ISO experience a plus.
  • Ability to lift 50-75 lbs and travel up to 20% within the region.

Responsibilities

  • Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, and production & process controls.
  • Establish and report metrics related to products and processes.
  • Ensure site manufactures products to meet CGMP requirements (21 CFR 212).
  • Perform product release activities per CGMP requirements.
  • Monitor CAPA in investigations and close when completed or escalate.
  • Communicate results from quality testing and collaborate with operations to meet production needs.
  • Maintain proficiency on production qualifications and participate in cross-functional projects.

Skills

Quality Assurance
Investigations / root cause analysis
Cross-functional collaboration
Regulatory understanding

Education

Bachelor’s degree in related science field
2+ years of related science experience

Tools

SAP
Microsoft Excel
Microsoft Word
Microsoft Outlook
Microsoft PowerPoint

Job description

Cardinal Health in Mississippi (Jackson) is seeking a Quality Assurance professional to support CGMP compliance, product release, and CAPA management. You will review documentation, perform investigations, and collaborate with cross-functional teams to ensure quality and regulatory alignment.

The role requires 2+ years in a related science field, a bachelor’s degree, ability to lift 50-75 lbs, and up to 20% travel. Night shift with 40 hours/week; salary range provided.

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