Gloved hand holding a pipette above a small container, with a beaker of red liquid on a lab plate in the background in the QAQC Lab on the University of Montana campus in Missoula, MT.

Montana Biotechnology Center

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FAQ

  • The Quality Assurance/Quality Control (QA/QC) Certificate Program is a specialized biotechnology workforce training program designed to prepare students and professionals for careers in quality-focused roles within the biotech and life sciences industries. Offered through a partnership between the University of California San Diego (UCSD) Extended Studies, the University of Montana (UM), and the Montana Biotechnology Center (BIOTECH), the program combines industry-relevant online instruction with optional hands-on laboratory training. Its modular format allows participants to complete the online module, the onsite practical module, or both, depending on their educational and career goals.

  • This program is designed for STEM graduates, early-career scientists, biotechnology professionals seeking QA/QC certification or professional development, and individuals interested in transitioning into biotechnology and life sciences careers. It is particularly well suited for those with backgrounds in biology, chemistry, microbiology, biochemistry, pharmacy, or related scientific disciplines who want to gain industry-relevant skills in quality systems, regulatory compliance, and laboratory best practices.

  • The program is structured as a flexible, modular training pathway consisting of two components: an asynchronous online/didactic module offered through the University of California San Diego (UCSD) Extended Studies and an onsite, hands-on laboratory module offered through the University of Montana (UM)/Montana Biotechnology Center (BIOTECH). Participants may complete either module independently or complete both for a more comprehensive QA/QC training experience.

  • Depending on the pathway selected, students may earn one or two credentials:

    • Online/Didactic Module Only:
      Graduate Certificate from the University of California San Diego (UCSD) Extended Studies
    • Onsite/Practical Module Only:
      Certificate of Completion from the University of Montana (UM)
    • Online + Onsite Modules:
      Graduate Certificate from UCSD Extended Studies and a Certificate of Completion from UM

  • The online (didactic) module includes comprehensive instruction in Quality Assurance and Quality Control principles for the biotechnology industry, as outlined in the UC San Diego Extended Studies QA/QC Certificate Program: https://extendedstudies.ucsd.edu/certificates/quality-assurance-and-control.

  • No. The online module may be completed independently and does not require completion of the onsite lab module. However, the onsite lab module can be taken as an elective component within the full QA/QC certificate pathway.

  • No. Students are not required to take the online module in order to participate in the hands-on experience. The program offers flexibility: participants may chose to complete only the optional in-person practical (lab) module offered by the University of Montana in Missoula and receive a Certificate of Completion for the practical training. 

    Alternatively, students may complete the online instructional module delivered by the University of California San Diego Extended Studies to earn a UCSD certificate, or complete both modules to receive certificates from both institutions. 

  •  

    The practical training module provides immersive, hands-on instruction in essential biotechnology QA/QC laboratory practices and regulatory standards. Participants receive training in laboratory safety, Good Laboratory Practices (GLP), and Good Documentation Practices (GDP), along with core laboratory skills such as pipetting techniques, test solution preparation, weighing, and sample handling. The module also includes hands-on experience with commonly used analytical instruments and technologies, including analytical balances, pH meters, UV-Vis spectrophotometers, High-Performance Liquid Chromatography (HPLC), particle size analyzers, and Fourier-Transform Infrared (FTIR) spectrometers.

    In addition to technical laboratory training, the CareerReady – QA/QC Career Accelerator component introduces participants to biotechnology industry workflows, including raw material inspection and release, compendial testing, material transfer procedures, product testing, method transfer, out-of-specification (OOS) investigations, and root cause analysis. Students also develop skills in report writing and drafting Standard Operating Procedures (SOPs) to support regulatory compliance, quality systems, and data integrity.

  • The onsite practical training module is held at the University of Montana (UM) and the Montana Biotechnology Center (BIOTECH) in Missoula, Montana, where participants receive hands-on training using industry-relevant laboratory equipment and biotechnology QA/QC workflows.

     

  • No, housing is not provided as part of the program. Accommodation is not included in the program cost, and participants are responsible for arranging and covering their own housing for the duration of the onsite practical module.

  • This program prepares graduates for entry-level and early-career roles in the biotechnology and pharmaceutical industries. Common career pathways include positions such as Quality Control Analyst, Quality Assurance Specialist, Biotechnology Laboratory Technician, and Manufacturing Quality Associate. These roles focus on ensuring product quality, regulatory compliance, and adherence to industry standards within laboratory and manufacturing environments.

  • Application instructions, program dates, and enrollment details are available on the program website. Prospective students should review this information carefully and follow the outlined steps to apply. If you have questions about eligibility, scheduling, or any other aspect of the program, you are encouraged to contact the program team for assistance.