QA Release Specialist II — Remote-Eligible

Radiometer; Fargo (ND); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Remote work eligible

Job summary

Aldevron, a Danaher operating company, is hiring a QA Release Specialist II to support final batch release and documentation review in a GMP environment. You will work with cross-functional teams to ensure compliance with cGMP and regulatory requirements at our Fargo, ND site.

The role emphasizes reviewing materials, collaborating across QA, QC, and Operations, and contributing to continuous improvement in quality documentation and procedures.

Qualifications

• Experience reviewing and auditing documentation in a regulated environment.
• Understanding of CPPs/CQAs and batch release criteria.
• Strong communication, critical thinking, and decision-making skills.

Responsibilities

• Review and evaluate batch documentation, production records, testing records, and supporting data for completeness and compliance with regulatory requirements.
• Evaluate evidence to determine CPPs/CQAs and other requirements for material disposition and final batch release.
• Identify and escalate quality issues that may impact product quality, patient safety, or regulatory compliance.

Skills

Quality systems

GMP experience

Auditing

cGMP knowledge

Education

Bachelor of Science in Life Science

Job description

Aldevron, a Danaher operating company, is hiring a QA Release Specialist II to support final batch release and documentation review in a GMP environment. You will work with cross-functional teams to ensure compliance with cGMP and regulatory requirements at our Fargo, ND site.

The role emphasizes reviewing materials, collaborating across QA, QC, and Operations, and contributing to continuous improvement in quality documentation and procedures.