Principal QC Specialist

As a Principal QC Specialist at Arcellx, you will be responsible for ensuring the quality and safety of our innovative cell therapies. This involves developing and managing QC testing laboratories, performing technical reviews of analytical testing, and leading laboratory investigations to resolve quality deviations. Your role is crucial in maintaining compliance with cGMP regulations and ensuring the effective delivery of our life-saving treatments.

To apply for the Principal QC Specialist role at Arcellx, candidates should have a Bachelor's degree in a relevant field, with advanced degrees preferred. Additionally, you should possess at least 12 years of industry experience (or 10 years with a Master's and 7 with a PhD) in Quality Control or related areas, particularly with expertise in molecular-based assays.

The salary range for a Principal QC Specialist at Arcellx is between $140,000 to $170,000 annually. The specific salary offered will take into account your years of experience and qualifications, alongside an appealing compensation package that includes bonuses and RSUs.

At Arcellx, we believe in investing in our people. As a Principal QC Specialist, you’ll have access to tuition reimbursement and professional development opportunities, enabling you to enhance your skills and advance your career within our innovative team.

At Arcellx, we pride ourselves on fostering a fun, diverse, and supportive environment. We believe that collaboration and inclusivity lead to the best results. As a Principal QC Specialist, you’ll be part of a high-performing team where every voice matters, and the atmosphere is informal yet focused on achieving our mission.

Arcellx offers a comprehensive benefits package that includes full medical, dental, and vision coverage for employees and their families, unlimited vacation days, a three-day weekend every month, and generous parental leave. Additionally, you can expect 401k employer contributions and various wellness programs aimed at supporting your overall well-being.

The Principal QC Specialist role at Arcellx is unique because you will play an integral part in building our QC testing lab from the ground up, contributing directly to revolutionary treatments that impact patients' lives. Your work will not only be impactful but also involve collaborating with some of the brightest minds in biotechnology, allowing you to exercise your creativity and expertise.

In responding to this question, highlight specific projects where you used GMP methods to ensure compliance with industry standards. Mention any challenges you faced and how you overcame them, demonstrating your problem-solving skills and attention to detail.

Discuss your organizational skills and how you assess the urgency and importance of tasks. Provide examples of how you've successfully managed tight deadlines and complex projects, emphasizing collaboration with team members to maintain quality.

Explain your methodology in conducting root cause analysis. Detail the steps you took, the stakeholders involved, and the outcomes. Focus on your analytical skills and how you translated findings into actionable improvements.

Talk about the resources you utilize, such as industry publications, regulatory websites, and professional associations. Illustrate your commitment to maintaining your knowledge of cGMP/ICH/FDA regulations through ongoing education and training.

Describe a systematic approach you would take, including immediate steps to investigate the anomaly, communicating with relevant departments, and documenting the process thoroughly. Emphasize your ability to lead and maintain high standards in quality management.

Discuss the importance of teamwork in quality control. Provide examples of successful collaborations that led to quality improvements or innovations, showcasing how diverse perspectives lead to better decision-making.

Detail your specific experience with molecular-based assays, including types you've worked with, the methodologies you've applied, and any meaningful outcomes your work has contributed to. Highlight your technical expertise and understanding of the relevance of these assays in the QC process.

Explain your structured method for creating an SOP. Discuss engaging stakeholders for input, ensuring regulatory compliance, and the need for clarity and accessibility in your documentation to facilitate effective training and implementation.

Highlight attributes such as attention to detail, strong analytical skills, and effective communication. You might share examples of how these skills have benefitted your work and the teams you’ve been part of.

Express your appreciation for feedback as an opportunity for growth. Provide examples of how you’ve applied feedback in your previous roles to improve your performance or processes, demonstrating your commitment to continuous improvement.