GxP QA Specialist - Biotech & Viro-Immunotherapies

Adapture; Rochester (MN); On-site; USD 75,000 - 95,000; Full time

Job summary

A growing biotech company in Rochester, Minnesota, is seeking a Quality Assurance Specialist to ensure compliance with quality standards in biopharmaceuticals. Responsibilities include facilitating QA strategy, conducting audits, and monitoring laboratory activities. Candidates should have a Bachelor’s in a relevant field and a minimum of 5 years' GxP experience. The ideal applicant will possess strong interpersonal skills and knowledge of GLP/GCP regulations. This role focuses on improving quality processes and meeting regulatory requirements.

Qualifications

• Minimum of 5 years in GxP or equivalent regulatory environment.
• Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
• Experience performing quality process audits and review of deviations.

Responsibilities

• Facilitate QA Strategy implementation and inspections.
• Perform audits on raw data and final reports.
• Monitor laboratory quality assurance activities.

Skills

Excellent knowledge of GLP and GCP requirements

Time and project management skills

Interpersonal skills

Verbal and written communication skills

Molecular biology background

Education

Bachelor’s degree in quality assurance or science-related field

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

A growing biotech company in Rochester, Minnesota, is seeking a Quality Assurance Specialist to ensure compliance with quality standards in biopharmaceuticals. Responsibilities include facilitating QA strategy, conducting audits, and monitoring laboratory activities. Candidates should have a Bachelor’s in a relevant field and a minimum of 5 years' GxP experience. The ideal applicant will possess strong interpersonal skills and knowledge of GLP/GCP regulations. This role focuses on improving quality processes and meeting regulatory requirements.