Specialist, Quality Assurance (Second Shift)

Scorpion Therapeutics; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Scorpion Therapeutics seeks a Quality Assurance Specialist to support GMP manufacturing and laboratory operations in biopharmaceuticals. You will review GMP documentation (IQ/OQ/batch records), perform environmental monitoring reviews, and lead shopfloor audits while assisting in deviation investigations and change controls.

The role requires a high school diploma and 4+ years in manufacturing with at least 2 years in GMP or FDA-regulated environments; aseptic techniques and batch record review

Qualifications

• High School Diploma required.
• 4+ years in manufacturing, laboratory, or related fields.
• At least 2 years in GMP or FDA-regulated environment preferred.
• Experience with aseptic techniques and batch record review preferred.

Responsibilities

• Independently manage projects ensuring cGMP compliance.
• Review and support GMP documentation (IQ, OQ, batch records).
• Perform environmental monitoring review and lead shopfloor audits.
• Assist in deviation investigations and change controls.

Skills

GMP compliance

Documentation review

Aseptic techniques

Batch record review

Environmental monitoring

Shopfloor audits

Deviation investigations

Change controls

Quality mindset

Education

High School Diploma

Tools

SAP

Veeva

GLIMS

Job description

Role: Quality Assurance Specialist supporting GMP manufacturing and laboratory operations in biopharmaceuticals, biologics, or vaccines.

Responsibilities: independently manage projects ensuring compliance with cGMP, review and support GMP documentation (IQ, OQ, batch records), perform environmental monitoring review, lead shopfloor audits, and assist in deviation investigations and change controls.

Requirements: High school diploma, 4+ years in manufacturing, laboratory, or related fields, with at least 2 years in GMP or FDA-regulated environment; experience with aseptic techniques and batch record review preferred.

HighValue: 2nd shift (evening), 10% travel, experience in aseptic manufacturing, biological drug substances or products, GMP with biologicals, and familiarity with relevant tools like SAP, Veeva, GLIMS.

WorkSetup: onsite with flexible schedule, supporting ongoing manufacturing activities.