GMP Quality Lead — Pharma Manufacturing & Compliance

Scorpion Therapeutics

Portage (IN)

On-site

USD 70,000 - 100,000

Full time

7 days ago
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Job summary

Scorpion Therapeutics in Indiana Portage is seeking a Manufacturing Quality Associate responsible for GMP compliance and product quality in pharmaceutical manufacturing. You will monitor operations, support environmental monitoring, perform quality testing, and help ensure manufacturing continuity.

The role requires a BS in chemistry or related field, 5+ years in pharma/biotech, and strong knowledge of GMPs, quality systems, and regulatory standards; auditing and GMP documentation review are key

Qualifications

  • BS in chemistry, biochemistry, or related field.
  • 5+ years in pharma, biotech, or medical device industries.
  • Strong knowledge of GMPs, quality systems, and regulatory standards.
  • Proficiency in GMP documentation review and auditing.
  • Excellent organizational, communication, and project leadership skills.

Responsibilities

  • Monitor manufacturing operations.
  • Conduct internal audits.
  • Investigate nonconformances.
  • Author and review GMP documentation.
  • Manage CAPAs.
  • Coordinate environmental monitoring.
  • Perform quality testing.
  • Support manufacturing continuity.

Skills

GMP knowledge
Quality systems
Regulatory standards
GMP documentation review
Auditing
Organizational skills
Communication
Project leadership
Pharma experience

Education

BS in chemistry or related field

Job description

Scorpion Therapeutics in Indiana Portage is seeking a Manufacturing Quality Associate responsible for GMP compliance and product quality in pharmaceutical manufacturing. You will monitor operations, support environmental monitoring, perform quality testing, and help ensure manufacturing continuity.

The role requires a BS in chemistry or related field, 5+ years in pharma/biotech, and strong knowledge of GMPs, quality systems, and regulatory standards; auditing and GMP documentation review are key

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