Quality Assurance Lead

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 world-changing 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

• Bachelor’s/Master’s 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 9001, 17025, 13485).

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

• Experience conducting internal or external audits.

• Strong project management, communication,  and problem-solving skills.

Preferred Certifications:

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

• ASQ (American Society for Quality) Certification

Benefits:

• Competitive salary & performance-based incentives

• Health, dental, and vision insurance

• Retirement plan & company-matching contributions

• Paid time off & holidays

• Professional development & certification reimbursement

• Relocation assistance (if applicable)

We encourage you to apply even if your experience doesn't 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 [email protected].