Quality Assurance Specialist - Biotechnology Resource Center

Position Summary:

The Quality Assurance Specialist supports the Quality Management System (QMS) at the Biotechnology Resource Center. This entry-level role is ideal for recent graduates with academic and internship experience in biomedical engineering, biotechnology, or related fields, the Position focuses on document control, batch record review, material release, and warehouse documentation, with opportunities to grow into ore advanced QA responsibilities.

Key Responsibilities:

Manufacturing & Documentation Support (45%):
* Assist with the preparation and issuance of batch records under supervision, including applying lot numbers as directed.
* Support the initial review of completed batch records for completeness and adherence to Good Documentation Practices (cGDP).
* Help organize and archive batch documentation for QA review and product disposition.
* Participate in basic inspections of incoming materials to verify documentation (e.g., CoAs, packing slips) under guidance.
* Assist in verifying manufacturing labels for accuracy and compliance with established procedures.
* Perform additional duties assigned to support QA operations.
* Support material status activities

Quality System Support (35%):
* Assist in document control activities, including document tracking, filing, and archiving.
* Help maintain training records and support the coordination of training sessions.
* Participate in the review of revised documents under supervision to ensure formatting and procedural compliance.
* Provide administrative support for quality investigations (e.g., nonconformances, CAPAs) as assigned.
* Follow all applicable SOPs and safety protocols, including University of Minnesota safety policies.

Facility & Equipment Support (20%):
* Support the coordination of routine calibration and maintenance activities by tracking schedules and logging completed work.
* Maintain logs and documentation related to equipment calibration and preventive maintenance.

Required Qualifications
* Bachelor's degree in biomedical engineering, Biotechnology, Life Sciences, or a related field; or a combination of education and relevant work experience to equal at least four years.
* Basic knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
* Ability to work in a fast-paced environment with strong attention to detail, organization, and time management skills.
* Capable of working individually and as a contributing member of internal and cross-functional teams.
* Excellent written, verbal, and interpersonal communication skills.

Required Skills/Abilities:
* Ability to review and edit documentation under supervision.
* Familiarity with cGMPs and willingness to learn and follow standard operating procedures.
* Good written, verbal, and interpersonal communication skills.
* Developing critical thinking and problem-solving skills.
* Attention to detail and ability to maintain accuracy and organization.
* Willingness to adapt to changing policies and procedures.
* Proficiency with Microsoft Office Suite (Excel, Word, Outlook).

Preferred Qualifications:
* 1-2 years of experience in a QA/QC or regulated laboratory environment.
* Familiar with problem-solving methodologies and capable of supporting root cause analysis under supervision.
* Advanced proficiency in Google Suite cloud tools (Docs, Sheets, Drive, etc.) for efficient documentation and collaboration.
* Eager to contribute to a team-oriented environment and grow within the biotechnology or life sciences industry.

At the Biotechnology Resource Center we harness the power of microorganisms - such as bacteria, fungi, and algae - to fuel growth of biotechnology projects both in the University community and beyond.

If you have a promising idea that has already been tested in the laboratory, we are here for you. We can help you develop and expand the scale of your work to make further progress, aid in testing, and further science, with the goal of product commercialization.

Housed on the University of Minnesota Twin Cities campus in St. Paul, Minnesota, we serve academic partners and industry clients from the fields of agriculture, biofuels, human therapeutics, industrial biotechnology, and veterinary medicine.

Pay Range: $54,000 to $58,000 annually; depending on education/qualifications/experience

Time Appointment Category: 75%-100% Appointment (If job description above does not specify appointment or expected weekly hours, assume a 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

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 employ@umn.edu or call (612) 624-8647.

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

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.

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 nation's 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 the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).