2nd Shift Pharma QA Specialist: GMP & Deviation Expert

HireLifeScience; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Job summary

HireLifeScience is seeking a Quality Assurance Specialist to support pharmaceutical, biologic, and vaccine manufacturing facilities. You will apply problem-solving skills in a multidisciplinary team and lead process improvements while ensuring QA alignment with GMP and regulatory requirements.

The role involves hands-on QA on the shop floor, batch reviews, change controls, and audits, with a focus on ensuring compliant operations and timely delivery of products.

Qualifications

• Minimum four years of experience in manufacturing, maintenance, laboratory, military environment, or related industry.

Responsibilities

• Manage project assignments independently under QA, reporting to QA Organization.
• Ensure compliance with cGMP, regulations, and Quality Management System.
• Provide QA shop floor support for IQ, OQ and other technical documents to meet milestones.
• Support batch review, alarm response, incursion response and deviation management.
• Lead shopfloor audits to identify and address housekeeping and compliance gaps.
• Assist cross-functional teams with change controls and cleaning validation documentation.
• May act as Quality Risk Assessment Lead.

Skills

Aseptic Manufacturing

Batch Record Review

Data Analysis

FDA Compliance

GMP

Personal Initiative

Quality Improvement Programs

Quality Standards

Teamwork

Education

High School Diploma or equivalent

Tools

Kneat

SAP

Veeva

GLIMS

Job description

HireLifeScience is seeking a Quality Assurance Specialist to support pharmaceutical, biologic, and vaccine manufacturing facilities. You will apply problem-solving skills in a multidisciplinary team and lead process improvements while ensuring QA alignment with GMP and regulatory requirements.

The role involves hands-on QA on the shop floor, batch reviews, change controls, and audits, with a focus on ensuring compliant operations and timely delivery of products.