Manufacturing Quality Associate (MQA) - 2nd & 3rd shift

Scorpion Therapeutics; Portage (IN); On-site; USD 70,000 - 100,000; Full time

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

Role

Manufacturing Quality Associate ensuring GMP compliance and product quality in pharmaceutical manufacturing.

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

Requirements

• 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

Preferred

• formal quality discipline certifications (e.g., ASQ, Lean Six Sigma)

High-value

focus on pharmaceutical manufacturing, GMP compliance, quality oversight, environmental monitoring, and quality testing activities.

Work setup

second or third shift, off-hours and weekend availability, with potential for fast-paced environment adaptation.