OQA Lead (Biotech)

Location: On-site in Fargo, North Dakota, United States

Company

Aldevron is a hirify.global operating company providing CDMO services that support the development of genomic medicine and other life-science therapies.

What you will do

• Independently review batch records and documents generated during GMP manufacturing.
• Assess GMP documentation for quality, accuracy, and compliance with established standards.
• Participate in investigations of deviations arising during GMP activities.
• Assist with tasks required to complete GMP manufacturing activities.
• Support accurate and reliable batch record generation within the Quality Assurance department.

Requirements

• High school diploma required; a Bachelor of Science in Biology, Microbiology, or a related field is preferred.
• Ability to independently perform assigned batch record reviews.
• Ability to review documentation accurately and on time.
• Ability to assess documentation and GMP activities against quality standards.
• Ability to work on-site in Fargo, North Dakota.

Nice to have

• Experience working in a GMP environment emphasizing Good Documentation Practices.
• Experience reviewing batch records, laboratory records, deviations, investigations, and change controls.
• Experience in a bioengineering quality function focused on data integrity and ALCOA++ principles.

Culture & Benefits

• Health care programs and paid time off are included among the available benefits.
• Work within a collaborative, mission-driven life-sciences organization focused on quality and continuous improvement.
• Contribute to products and services supporting genomic medicine and life-changing therapies.