GMP Quality Assurance Specialist

GlaxoSmithKline; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

GlaxoSmithKline in the United States seeks an operational quality oversight professional at a manufacturing site. You will collaborate with production, laboratories, engineering and quality teams to ensure processes comply with cGxP standards, provide independent QA oversight, and maintain inspection readiness.

You will review batch records, support quality decisions, and escalate issues to protect product quality.

Qualifications

• GxP knowledge and GMP/compliance understanding.
• Experience in batch record review and QA decision-making.
• Collaborates with production, labs, engineering and QA.

Responsibilities

• Ensure GMP processes and regulatory requirements are followed, maintaining inspection readiness.
• Maintain shopfloor oversight and be the first line of contact for quality issues and escalations.
• Perform cGMP documentation reviews to ensure data integrity and GDP compliance.
• Review and final approve batch records and related documentation.

Job description

GlaxoSmithKline in the United States seeks an operational quality oversight professional at a manufacturing site. You will collaborate with production, laboratories, engineering and quality teams to ensure processes comply with cGxP standards, provide independent QA oversight, and maintain inspection readiness.

You will review batch records, support quality decisions, and escalate issues to protect product quality.