Quality Assurance Specialist

Position Summary
Are you passionate about science and have experience in quality assurance activities? This could be the opportunity for you!
As a Quality Assurance (QA) Specialist, you will support the Biotechnology Resource Center (BRC) located on the University's St. Paul campus.

Key Responsibilities:

65% Routine Duties:
-Coordinate with manufacturing for the issuance, and lot numbering of batch records.
-Assist in the quality review of batch records for product manufacturing.
-Assist with QA final review and disposition of products.
-Conduct inspections of incoming materials to ensure specifications are met.
-Conduct inspections of manufacturing labels to ensure accuracy and compliance with customer requirements.
-Coordinate facility calibration and maintenance activities, including the review of calibration results.
-Follow applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
-Comply with all site safety requirements, SOPs, and manufacturing documentation.
-Follow University of Minnesota safety policies and practices.
-Perform additional duties as assigned.

30% Quality System Duties:
-Assist in the quality review and release of newly written or revised documents per prescribed standard operating procedures.
-Maintain in-house training programs, including training matrix, training files, and annual audit of training files.
-Perform QA document control functions, including document tracking, processing, review, distribution, release, and archiving of documents.
-Assist with nonconformance, CAPA, and complaint investigations.

5% Instruction:
-Provide hands-on training for junior or undergraduate student workers in the BRC.

Required Qualifications:

-BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years; position involves comparing, verifying and reconciling data to help department achieve overall objectives.
-Ability to work in a fast-paced environment with exceptional attention to detail, organization, and time management skills.
-Capable of working individually and as a contributing member of internal and cross-functional teams, maintaining good communication skills, both verbally and in writing.
-Familiar with cGMPs and the ability to follow standard operating procedures.
-Excellent written, verbal, and interpersonal communication skills.

Preferred Qualifications:

-Proficient in problem-solving methodologies used in root cause investigations (e.g.6M's).
-Strong critical thinking and problem-solving skills.
-Ability to adapt quickly to changing policies and procedures.
Proficient with Microsoft Office, Google Suite, and Adobe Acrobat.

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also 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

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

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).