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
⢠Bachelorâ™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.

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

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