QA Associate: GMP & Biotech Quality

TechDigital Group; Bothell (WA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to ensure compliance with manufacturing regulations. This role involves reviewing batch production records, monitoring processing stages, and supporting audits to maintain product quality. The ideal candidate will have a strong background in biotech manufacturing and regulatory compliance, with the opportunity to guide less experienced staff. Join a dynamic team committed to excellence in product quality and regulatory adherence, making a meaningful impact in the biotech sector.

Qualifications

• 2+ years of experience in a regulated environment focused on product quality.
• Knowledge of US and EU cGMP regulations is essential.

Responsibilities

• Conducts batch production record reviews and approvals for product release.
• Monitors processing stages and ensures compliance with specifications.
• Provides guidance to less experienced staff in GMP areas.

Skills

Quality Assurance

Regulatory Compliance

Problem Solving

Biotech Knowledge

Education

B.S. in Biology

B.S. in Chemistry

Equivalent Discipline

Tools

Oracle

BMRAM

MES

Veeva Infinity

Job description

An established industry player is seeking a dedicated Quality Assurance professional to ensure compliance with manufacturing regulations. This role involves reviewing batch production records, monitoring processing stages, and supporting audits to maintain product quality. The ideal candidate will have a strong background in biotech manufacturing and regulatory compliance, with the opportunity to guide less experienced staff. Join a dynamic team committed to excellence in product quality and regulatory adherence, making a meaningful impact in the biotech sector.