Quality Assurance Specialist

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

This role ensures that science, data, and processes meet biopharma regulatory and quality standards.

About

A growing biotech company based in Rochester, Minnesota. Our mission is to provide innovative solutions to support viral, genetic, and cell-based therapies in order to improve patient quality of life worldwide. We are a leading provider of viral and cellular products and research services with a focus on viro-immunotherapies. Also provides correlative testing for clients who perform oncolytic virus clinical.

We are currently seeking a proactive, reliable, and experienced Quality Assurance Specialist with outstanding interpersonal and technical skills. Interested candidates should have GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.

Key Responsibilities

• Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.
• Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.
• Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.
• Review all documentation for adherence to organizational quality standards.
• Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.
• Provide QA support for change controls, deviations, investigations, CAPA’s and effectiveness checks.
• Develop and maintain compliance-related trending metrics and reports.
• Provide recommendations for necessary corrections and improvements to quality processes...
• Provide oversight of personnel training record management.
• Provide QA support of internal and external audits, as assigned.
• Review and update Quality Assurance procedures.
• Maintain audit forms and QA records.
• Other duties as needed.

Qualifications

• Bachelor’s degree in quality assurance or science-related field.
• Minimum of 5 years in GxP or equivalent regulatory environment.
• Excellent knowledge of GLP and GCP requirements.
• Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
• Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.
• Able to understand published methodology to audit existing test methods and ensure accuracy.
• Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.
• Experience performing quality process audits and review of deviations and CAPA.
• Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).
• Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.
• Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
• Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
• Background in molecular biology, virology and/or serology is a plus.
• Contract research organization (CRO) experience is a plus.
• Experience with eQMS (Qualio) is a plus.