Quality Assurance Specialist 3, Floor Support

Scorpion Therapeutics; Winston-Salem (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

Scorpion Therapeutics in Winston-Salem, NC seeks a Quality Assurance Specialist III to provide real-time QA support in cGMP aseptic manufacturing, ensuring compliance and accurate documentation on sterile, validated processes.

You will review batch records, environmental data, and facility alarms; support deviation investigations, CAPAs, and audits; and uphold gowning and cleanroom protocols through strict onsite presence.

Qualifications

• Bachelor's in an applied science or equivalent.
• 5+ years of QA experience in GMP manufacturing, aseptic preferred.
• Strong knowledge of cGMP regulations and sterile manufacturing.
• Excellent documentation and cross-functional communication.

Responsibilities

• Review batch records and environmental data.
• Monitor facility alarms and deviations.
• Support deviation investigations, CAPAs, and audits.
• Ensure gowning and cleanroom protocols are strictly followed.

Skills

cGMP knowledge

Documentation skills

Environmental monitoring

Cross-functional communication

Education

Bachelor's in Applied Science

Job description

Role: Quality Assurance Specialist III

providing real-time QA support in classified manufacturing environments, primarily in cGMP-compliant aseptic drug production. Objectives include ensuring manufacturing compliance, documentation accuracy, and issue resolution within sterile, validated processes.

Responsibilities encompass reviewing batch records, environmental data, and facility alarms; supporting deviation investigations, CAPAs, and audits; and maintaining strict gowning and cleanroom protocols.

Requirements: Bachelor's in an applied science or equivalent; 5+ years of QA experience in GMP manufacturing, with aseptic manufacturing preferred.

Skills include thorough knowledge of cGMP regulations, strong documentation and analytical abilities, and effective cross-functional communication.

High-Value: GMP aseptic drug manufacturing, cleanroom operations, documentation review, deviation management, internal audits.

Work setup: exclusively onsite; full gowning and cleanroom presence required; not eligible for remote or hybrid arrangements.