Quality Specialist II

As a Quality Specialist II at Freenome, you will be responsible for supporting several QMS compliance activities, including batch record reviews, managing nonconformance and CAPA systems, authoring and revising SOPs, and collaborating with various teams to resolve documentation errors. You'll also participate in regulatory inspections and internal audits to ensure that all processes meet FDA and ISO standards.

To qualify for the Quality Specialist II role at Freenome, you’ll need a BS/BA in a life science, engineering, or related field, along with at least 3 years of QA experience in an FDA-regulated industry. Familiarity with regulations like ISO 13485:2016 and CLIA guidelines is ideal. Strong analytical skills, attention to detail, and the ability to adapt in a fast-paced environment are also essential.

Freenome is committed to fostering a high-performing culture, providing employees with opportunities for professional growth through training, collaboration, and mentoring. As a Quality Specialist II, you'll have the chance to contribute to QMS improvements and participate in management review processes, further enhancing your skills and career prospects.

At Freenome, the team environment for the Quality Specialist II is collaborative and dynamic. You’ll work closely with cross-functional teams, including Quality Control, to resolve issues and improve compliance practices. The culture emphasizes respect, open communication, and teamwork, creating an engaging atmosphere where all voices are heard.

As a Quality Specialist II at Freenome, you can expect a comprehensive benefits package that includes competitive salary ranges, pre-IPO equity options, cash bonuses, and extensive medical, financial, and wellness benefits. The company also values diversity and inclusion, ensuring that all employees feel welcome and supported.

When responding, mention specific methodologies such as Six Sigma, CAPA, and Root Cause Analysis, and explain how you have applied them in past roles. Highlight your commitment to quality and detail the successful outcomes of implementing these processes.

Provide a detailed example that outlines the issue, your investigative process, and the steps you took to resolve it. Emphasize your analytical skills and how addressing this nonconformance improved overall operations.

Discuss your familiarity with the specific regulations and your proactive approach to maintaining compliance, such as conducting regular audits, reviewing documentation, and staying updated on regulatory changes.

Share specific examples where you've authored or updated SOPs, emphasizing your understanding of the importance of clear and accessible documentation in maintaining quality standards.

Outline your collaborative approach, the roles of other team members, and focus on how effective communication and teamwork contributed to a successful resolution of the issue.

Discuss your time management techniques, such as categorizing tasks by urgency and importance, and explain how you've handled competing priorities in previous roles.

Explain your systematic approach to auditing, including preparing audit checklists, documenting findings, and following up on corrective actions to ensure continuous improvement.

Mention techniques such as taking relevant courses, participating in professional organizations, or following industry publications and leaders through forums and social media.

Describe a particular KPI, its significance for the quality systems, how you established baseline metrics, and any improvements that resulted from tracking this indicator.

Share your passion for cancer detection and the biotech field, and discuss how Freenome’s mission aligns with your personal values and career aspirations, emphasizing your enthusiasm for contributing to innovative healthcare solutions.