Quality Assurance Specialist II

About the Job

Minnesota Biomanufacturing Services (MBS), located on the University of Minnesota's St. Paul campus, is seeking a Quality Assurance Specialist II to help strengthen and support the facility's Quality Management System (QMS). In this role, you'll play a key part in ensuring our biomanufacturing processes run smoothly, our documentation is accurate, and our quality standards remain consistently high. You'll work closely with production, technical staff, and other internal partners to maintain reliable operations, improve quality systems, and support a culture where accuracy, safety, and continuous improvement are central to our work.

Location and Work Environment: Onsite at our University of Minnesota's St. Paul campus

Work Schedule: The standard schedule for this role is Monday through Friday, totaling 40 hours per week, with hours aligned to daytime operations. Some flexibility within the work week may be needed to support production needs across different operational periods and ensure continuity of activities.

Primary Responsibilities:

65% - Quality Operational Support

• Batch record management - Coordinate batch record lifecycle activities, including review, issuance, and lot numbering with production.
• Label inspection - Inspect customer‑finished material labels to ensure conformance with internal procedures.
• Production record review - Perform QA review and release of production records; complete required quality documentation in alignment with internal standards.
• Incoming material inspection - Receive, inspect and release incoming materials; support supplier‑related activities such as retrieving and reviewing certificates of analysis and responding to client documentation requests.
• Material shipment coordination - Coordinate material shipments with internal and external stakeholders and maintain accurate shipping and distribution records.
• Quality system adherence - Comply with MBS's Quality Manual, SOPs, Work Instructions, and site safety requirements.
• UMN safety compliance - Understanding and following University safety policies related to laboratory work, chemical handling, PPE use, and facility access.

30% - Quality Management System Support

• Controlled document management - Develop, revise, and maintain controlled documents (SOPs, Work Instructions, Forms, Batch Records, Logs) within the QMS.
• QMS audit readiness - Assist in maintaining QMS records, systems, and documentation to ensure customer audit readiness and consistent quality representation.
• Training program maintenance - Maintain facility training matrices, communicate document‑revision training, and support production and quality training requests.
• Training compliance - Adhere to internal and university training requirements.
• Additional duties - Perform additional responsibilities as assigned.

5% - Quality Culture & Process Improvement

• Hands‑on training - Provide training and guidance to junior staff or student workers within MBS.
• Quality culture initiatives - Support efforts that strengthen quality culture, documentation accuracy, and operational consistency.

The employer reserves the right to change or assign duties to this position*

Qualifications

Required Qualifications:

• BA/BS in a scientific or related field with at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years inclkuding 3-5 years of experience in quality assurance.
• Operational QA experience - Proven ability to perform QA tasks such as batch record review, product release, and material shipment coordination in a production environment.
• Document control experience - Experience administering document control systems, including DCO workflows and record retention.
• Quality frameworks - Familiarity with structured quality frameworks (e.g., ISO 9001).
• Regulatory familiarity - Awareness of cGMP‑related standards (21 CFR 210, 21 CFR 211, ICH Q7) and ability to translate these concepts into practical SOPs.
• Organizational skills - Strong organizational and project‑management skills with the ability to manage daily throughput while supporting process improvements.

Preferred Qualifications:

• Familiarity with key regulatory and quality frameworks, including 21 CFR 210, 21 CFR 211, ICH Q7, ALCOA+ data integrity principles, and ISO 9001.
• Familiarity with Enterprise Resource Planning (ERP) systems.
• Proficiency in structured root‑cause analysis methodologies, such as the 6M's.
• Strong critical thinking and analytical problem‑solving skills.
• Ability to adapt quickly to evolving policies, procedures, and client requirements.
• Proficiency with Microsoft Office, Google Suite, and Adobe Acrobat, with the ability to navigate electronic documentation workflows effectively.

About the Department

The Quality department at Minnesota Biomanufacturing Services (MBS) is responsible for ensuring oversight of all quality‑related production and QMS activities so project deliverables meet expectations for partners across academia, startups, and industry. The Quality Assurance Specialist II advances this mission by supporting daily quality operations, contributing to continuous improvement, and helping maintain a dependable framework for bioprocess development and scale‑up.

Pay and Benefits

Pay Range: $68,000-$78,000 annually ($32.69-$37.50 hourly) depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

How To Apply

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail jobcentr@umn.edu.

Diversity

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Employment Requirements

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

About University of Minnesota

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nations most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.