GMP QC Coordinator: Data-Driven QA & Compliance

eTeam; Durham (NC); On-site; USD 37,000 - 41,000; Full time

Job summary

eTeam is seeking a Quality Control Specialist to oversee in-process QC, release, raw materials and stability samples, ensuring GMP compliance and data integrity across development and commercial programs. The role emphasizes strong written and oral communication, SOP development, and collaboration with QA, Manufacturing and Facilities to support audits and investigations.

Minimum experience in GMP QC labs and familiarity with inventory systems and sample management are required.

Qualifications

• 6 years related GMP QC laboratory experience with high school or equivalent.
• 4 years related GMP QC laboratory experience with Associate’s degree or higher.
• Strong understanding of sample receipt and inventory management in a GMP lab.
• Excellent written and oral communication skills with technical writing experience.

Responsibilities

• Oversee QC in-process, release, raw material, and stability samples and data.
• Ensure GMP compliance and support FDA/EMEA regulatory interactions and audits.
• Manage sample tracking and inventory for commercial and development samples.
• Generate sample submission forms and process returned results.

Skills

GMP knowledge

Technical writing

Quality control

Inventory management

Education

High School with GMP QC experience

Associate’s degree in science with GMP QC experience

Bachelor’s degree in relevant science with GMP QC experience

Tools

LIMS

Job description

eTeam is seeking a Quality Control Specialist to oversee in-process QC, release, raw materials and stability samples, ensuring GMP compliance and data integrity across development and commercial programs. The role emphasizes strong written and oral communication, SOP development, and collaboration with QA, Manufacturing and Facilities to support audits and investigations.

Minimum experience in GMP QC labs and familiarity with inventory systems and sample management are required.