GMP Release & Quality Assurance Lead

Biopharma Careers; Zebulon (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK US in Zebulon seeks an experienced QA professional to provide operational quality oversight across GMP areas, ensuring adherence to cGMP standards and GDP data integrity. You will review documentation, release products, and lead CAPA and continuous improvement initiatives.

The role requires a Bachelor’s degree in a scientific/engineering/quality discipline and 4+ years in pharmaceutical manufacturing, quality, or related fields. On-site work with potential night/weekend coverage.

Qualifications

• Bachelor’s Degree and 4+ years of GMP pharmaceutical experience.
• Experience with deviations, CAPA, change control, and document control.
• Able to apply QMS and GMP principles to day-to-day role.

Responsibilities

• Provide quality oversight for GMP areas including OSD, MDI and MDPI, Laboratories, Warehouse, and Facility/Utility areas.
• First line of contact for initial management of quality issues and deviations.
• Review, release and second check of batch records for cGMPs and GDP data integrity.
• Provide guidance during GMP activities to detect potential quality issues and support CAPA identification.
• Spot-check activities to ensure compliance and escalate deviations for timely remediation.
• Collaborate with cross-functional teams to implement corrective/preventive actions and continuous improvement.

Skills

Data Integrity

Detail‑Oriented

Digital Fluency

GxP Regulations

Influencing

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor’s degree in scientific/engineering/quality

Tools

MERP

Microsoft Office

Power BI

VQD

Job description

GSK US in Zebulon seeks an experienced QA professional to provide operational quality oversight across GMP areas, ensuring adherence to cGMP standards and GDP data integrity. You will review documentation, release products, and lead CAPA and continuous improvement initiatives.

The role requires a Bachelor’s degree in a scientific/engineering/quality discipline and 4+ years in pharmaceutical manufacturing, quality, or related fields. On-site work with potential night/weekend coverage.