Drug Product QA & Validation Specialist

American Society for Quality; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

American Society for Quality seeks a QA Specialist, Drug Product to drive QA oversight for DP manufacturing processes from startup through commercial operations. You will oversee QA day-to-day activities and address issues to ensure controlled, compliant production.

The role requires a Life Sciences or Engineering background with GMP experience, strong documentation skills, and cross-functional collaboration to support regulatory inspections and process improvements.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering or equivalent with 2+ years of applicable industry experience; OR, Master’s degree in Life Sciences or Engineering with 0+ years of applicable experience.
• 1+ years of experience working in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Responsibilities

• Supports development of documents, processes and procedures for the Drug Product program.
• Oversees change management to maintain validated state from startup to commercial operation.
• Oversees lifecycle documentation including risk assessments, specs, validation plans and reports.
• Generates, reviews and approves QA documentation and validation lifecycle documents.
• Provides QA support for manufacturing operations in a cGMP facility.
• Ensures project and operation quality objectives are met within timelines.
• Provides shop floor QA support including line clearances and alarm responses.
• Participates in improvement initiatives and regulatory inspections.

Skills

QA oversight

GMP compliance

cGMP

Documentation

Risk assessment

Cross-functional teamwork

Problem solving

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

Tools

Trackwise

Veeva

Smartsheet

Kneat Validation

PAS-X

Job description

American Society for Quality seeks a QA Specialist, Drug Product to drive QA oversight for DP manufacturing processes from startup through commercial operations. You will oversee QA day-to-day activities and address issues to ensure controlled, compliant production.

The role requires a Life Sciences or Engineering background with GMP experience, strong documentation skills, and cross-functional collaboration to support regulatory inspections and process improvements.