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Reagent Quality Control Inspector, Team Leader

Nautilus Biotechnology

Nautilus Biotechnology

Quality Assurance
San Carlos, CA, USA
Posted on Wednesday, May 22, 2024

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing deep, hard science with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines.

We are hiring a Reagent Quality Control Inspector Team Leader to join our growing organization. This role will be part of the Operations team and lead quality control systems implementation and inspection of reagents both internally and externally (CMO’s). They will be responsible for audits and continual review of production processes. The individual will be collaborating with the Development teams to evaluate and implement specifications and procedures used in the inspection of reagents. They will support the implementation and updating of quality inspection results into batch records and integration into the LIMS.

This position is located in San Carlos, CA and requires full time presence on site.

Responsibilities:

  • Work with the Analytics Development team to be knowledgeable of reagent specifications and associated QC inspection processes.

  • Transfer analytical methods and QC inspection processes into the production environment; train quality inspectors to execute inspection processes and interpret results for evaluation against specifications.

  • Work with the Analytics Development team to validate inspection and performance results against specifications; Collaborate to make changes to specifications so that they align with actual experimental results.

  • Review production processes on an ongoing basis and optimize to resolve potential quality issues.

  • Carry out QC inspection and audits for internally produced reagents; resolve non-conformances and lead Root Cause/Corrective Action initiatives to resolve quality issues. Perform follow-up and audits to ensure that corrective actions have been implemented and are yielding improved results.

  • With the Analytics team, develop incoming material inspection processes/specifications, implement and perform incoming material inspections; identify non-conforming materials and collect data for follow up/resolution of quality issues with the material suppliers.

  • Periodically assess internal reagent inventory to ensure that shelf-life and storage condition specifications are maintained.

  • Create quality metrics report and update results on a weekly basis.

  • Evaluate the QC processes of CMO partners; ensure that requested quality inspection procedures are implemented by CMO’s; evaluate CMO quality data and review incoming reagent lots to accept or reject as required.

  • Support the implementation of Reagent Kit production lines (internally and at CMO’s) by setting up kit specifications and inspection points; Implement fail safe systems that will prevent the shipment of defective/non-conforming reagent kits.

  • Provide team leadership to a small QC team to ensure that weekly team priorities are being completed, adequate training is provided, inspection backlogs are minimized, cross functional team engagement to support the team is coordinated, and that the team is working together to perform the scope of team activities.

Requirements:

  • BS Biochemistry, Chemical Engineering or other relevant degree required.

  • Minimum of 5 years’ experience working in a reagent production environment and a minimum of 3 years’ experience working in a quality control capacity.

  • Prior experience with the production and quality management of reagents and reagent kits.

  • Prior experience in developing and managing quality inspection processes for reagents and reagent kits.

  • Knowledge of reagent inspection techniques (HPLC, Gels, basic assays, etc.) and ability to perform required inspection processes.

  • Ability to create and report on metrics to monitor reagent production quality.

  • Must be able to work successfully in a cross functional environment and develop strong cooperative working relationships with cross functional team members.

  • Demonstrate the ability to troubleshoot quality issues and develop/implement corrective actions to resolve quality issues.

  • Ability to document quality process SOP’s and train QC Analysts on reagent specifications and required quality inspection protocols.

  • Prior experience in working with CMO’s and external reagent suppliers to implement quality programs and evaluate incoming reagent quality.

  • Ability to lead Material Review Board meetings to assess/disposition deviations and non-conforming materials.

  • Demonstrated ability to lead a team to complete work on time and at a high level of quality to support the production environment.

  • Prior experience with implementation and ongoing use of LIMS.

  • Expertise in use of Microsoft Office Suite, especially MS Excel.

Nautilus Team Culture

  • We are curious go-getters: this is a team of life-long learners who aren’t afraid to tackle the big challenges while continuously pushing ourselves forward

  • We are detail oriented: we do great science by working smart and with diligence, and by learning from our mistakes

  • We are easy to work with: we want our workplace to be one where everyone can share their perspective and be treated with respect and kindness

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