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Quality Assurance Lead

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1 Vacancy
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Job Location drjobs

South San Francisco, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

About Plasmidsaurus

Plasmidsaurus is on a mission to accelerate new cures and promote a healthier planet by unlocking a new level of productivity for scientists who use DNA tools to bring their ideas to life. Our DNA sequencing tools are used daily by thousands of innovators including Nobel prize winners dynamic biotech startups research labs and DIY biohackers. Our global network of labs operates day and night to enable worldchanging discoveries. In 2024 we saved these scientists 2 million hours of time radically accelerating their research. Every team member at Plasmidsaurus plays a crucial role in driving forward the future of biotech research.

Job Overview

We are seeking an experienced Quality Assurance Lead to develop implement and oversee our Quality Management System (QMS) in preparation for ISO certification (ISO 17025. This role will ensure compliance with regulatory requirements industry standards and best practices in DNA processing sequencing and laboratory operations.

Key Responsibilities

  • Develop and implement a QMS aligned with ISO standards.

  • Lead ISO certification efforts and ensure regulatory compliance.

  • Establish SOPs document control and quality policies.

  • Conduct internal audits manage CAPA and drive continuous improvement.

  • Oversee risk management root cause analysis and training programs.

Qualifications

  • Bachelors/Masters in molecular biology genomics or a related field.

  • 8 years in QA QC or regulatory compliance in a biotech/lab setting.

  • Experience with ISO certification (ISO.

  • Knowledge of DNA processing LIMS GxP FDA CLIA CAP preferred.

  • Experience conducting internal or external audits.

  • Strong project management communication and problemsolving skills.

Preferred Certifications:

  • ISO 17025:2017 or ISO 9001:2015 Lead Auditor Certification

  • ASQ (American Society for Quality) Certification

Benefits:

  • Competitive salary & performancebased incentives

  • Health dental and vision insurance

  • Retirement plan & companymatching contributions

  • Paid time off & holidays

  • Professional development & certification reimbursement

  • Relocation assistance (if applicable)

We encourage you to apply even if your experience doesnt perfectly align with the job description as we seek out diverse and creative perspectives. Team members who love to learn and collaborate in an inclusive environment will thrive with us. We are an equal opportunity employer and do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. If you need additional accommodations to feel comfortable during your interview process please let us know at

Employment Type

Full-Time

Department / Functional Area

Operations

About Company

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