Quality Assurance Intern

We are looking to add a Quality Assurance Intern for our team this summer to help maintain and continuously improve our Quality Management System. The ideal candidate would be a graduating senior pursuing their undergraduate degree or a current/graduating graduate student.

Responsibilities

• Become familiar with QMS processes and ISO 9001:2015 requirements
• Serve as the eQMS administrator, including supporting document migration deliverables, and user troubleshooting 
• Support Manufacturing Operations, including reviewing and uploading batch records, calibration records, and forms/templates to eQMS
• Facilitate the NCR/CAPA/Change Control/ meetings, including documenting meeting minutes/action items, trending/reporting on quality system metrics, and triaging/escalating quality issues
• Liaison with internal stakeholders to ensure appropriate documentation and timely resolution and follow-up of customer feedback and complaints.
• Support internal, customer, and regulatory audits, including document staging, audit logistics (i.e., scribing), and working with internal stakeholders on resolving audit findings.

Requirements

• A passion for learning new things, wearing multiple hats, and being a team player.
• Experience working in regulated environments (i.e. 21 CFR Part 820, ISO 13485:2016, CE-Mark, MDD/IVDD, CLIA/CAP) within the pharmaceutical, medical device, in-vitro diagnostics industries
• Knowledge of fundamental quality engineering concepts, such as GxPs, root cause investigation techniques, design controls, risk management, purchasing controls, process validation, equipment calibration, process/product metrics, and auditing practices
• Experience working cross-collaboratively on Core Teams for Design Control projects.
• Undergraduate degree in an accredited scientific or engineering discipline (i.e. Chemistry, Molecular/Cell Biology, Biochemistry, Biomedical/Chemical/Mechanical Engineering)
• Prior experience in a full-time Quality Assurance or regulatory affairs compliance role within the biotechnology and/or healthcare space. 
• Work in our Bay Area office in Emeryville, CA multiple days each week.

Helpful but not required:

• Prior experience with using, administering, migration, and implementing eQMS systems 
• Lead Auditor certification to ISO 9001:2015 or ISO 13485:2016
• Prior experience working with flow cytometry technology for applications in hematology or cell therapy in an academic or industry setting.

The hourly rate for this internship is $25.00 per hour.