Quality Assurance Specialist II

Job

Job Family:
Research

Contract Type:
Full-Time

Employment Status:
Regular

Job Code: 8352PG

Employee Class:
Civil Service

Location:

Twin Cities

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.

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

• Handson 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*

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 including 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 cGMPrelated 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…