Quality Assurance Specialist

Insight Global is seeking to hire a Quality Assurance Specialist for a growing biotech company based in Rochester, Minnesota. Their mission is to provide innovative solutions to support viral, genetic, and cell-based therapies in order to improve patient quality of life worldwide. They are a leading provider of viral and cellular products and research services with a focus on viro-immunotherapies, in addition to providing 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 of change controls, deviations, investigations, CAPA's and effectiveness checks.

* Develop and maintain compliance-related trending metrics and reports.

* Makes appropriate recommendations for correction and improvement as may be necessary.

* Provide oversight of personnel training record management.

* Provide QA support of internal and external audits, as assigned.

* Reviews and updates Quality Assurance procedures.

* Maintains audit forms and QA records.

* Other duties as needed.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience
- Bachelor's degree in a science-related field or quality assurance
- 4+ years of experience in an ISO 9001 environment from a biotech or biopharma company.
- Comfortable relocating to Rochester, MN.
- Strong experience with GMP, GLP, and/or GCP.

Nice to Have Skills & Experience
- Experience implementing an ISO 9001 environment.
- Experience with ISO 17025 and/or ISO 17034.
- Experience with eQMS system (Qualio).

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.