Quality Assurance Lead

As the Quality Assurance Lead at Plasmidsaurus, you'll be tasked with developing and implementing our Quality Management System (QMS) in preparation for ISO certification, particularly ISO 17025. Key responsibilities include leading certification efforts, ensuring regulatory compliance, establishing SOPs, conducting internal audits, and managing corrective actions. Additionally, you'll play a vital role in risk management and the continuous improvement of our laboratory operations.

To qualify for the Quality Assurance Lead role at Plasmidsaurus, candidates should possess a Bachelor’s or Master’s degree in molecular biology, genomics, or a related field, along with at least 8 years of experience in QA, QC, or regulatory compliance within a biotech or lab environment. Familiarity with ISO certifications, particularly ISO 9001, 17025, and 13485, as well as knowledge of DNA processing and regulatory standards are essential.

At Plasmidsaurus, we are committed to the professional growth of our team members, including our Quality Assurance Lead. We offer competitive salaries, performance-based incentives, and benefits that include reimbursement for professional development and certifications. This support reflects our commitment to fostering innovative minds who are eager to grow within the continuously evolving biotech landscape.

Candidates applying for the Quality Assurance Lead position at Plasmidsaurus should ideally have hands-on experience with ISO certification processes, particularly ISO 17025 and ISO 9001. Experience in conducting internal/external audits and an understanding of DNA processing, GxP, FDA, CLIA, and CAP standards will enhance your ability to excel in this role. We're looking for candidates with strong project management and excellent communication skills.

Plasmidsaurus fosters an inclusive and collaborative work environment where creativity and diverse perspectives are valued. As a Quality Assurance Lead, you will be part of a dynamic team that thrives on learning and innovation. We encourage open communication and support one another in making significant contributions to the biotech field, all while working in a light-hearted and engaging atmosphere.

To effectively prioritize tasks when developing a Quality Management System, start by understanding the organization's goals and regulatory requirements. Focus on creating a timeline that addresses critical compliance issues first, while simultaneously mapping out long-term objectives. Effective communication with team members will help allocate tasks based on expertise, ensuring smooth progress toward ISO certification.

When discussing your experience with ISO 17025, emphasize specific instances where you have led a laboratory through the certification process. Talk about the challenges you encountered, the steps you took to achieve compliance, and how you facilitated training and audits to instill a quality culture among team members. Demonstrating your understanding of the standard’s requirements will leave a positive impression.

For conducting internal audits effectively, I employ a systematic approach that includes developing an audit plan based on risk assessments, clear objectives, and defined criteria. I also facilitate open communication with staff, ensuring they understand the audit process and fostering a culture where feedback is valued. After completing audits, I focus on documenting findings meticulously and implementing follow-up actions.

When addressing corrective and preventive actions (CAPA), I promptly investigate the root cause of any non-conformities. I collaborate with team members to implement solutions that not only rectify the immediate issue but also prevent future occurrences. It's essential to ensure that all actions are documented and communicated effectively to promote a continuous improvement culture.

My approach to training staff on quality policies involves developing comprehensive training programs that are engaging and easy to comprehend. I prioritize hands-on experiences, utilizing workshops and role-playing scenarios to reinforce learning. Additionally, I ensure that training materials are readily accessible, allowing employees to reference them whenever needed.

To assess the effectiveness of a Quality Management System, I focus on key performance indicators (KPIs) and regularly review audit results and feedback from staff. By analyzing data trends over time, I can identify areas for improvement and ensure alignment with regulatory requirements. Continuous monitoring and feedback loops help maintain the system's effectiveness.

In my previous roles, I've gained extensive experience with DNA processing techniques, including sequencing and sample preparation. I have worked closely with laboratory operations, compliance, and quality assurance principles to ensure that all procedures align with industry standards. Discussing specific projects or technologies will enhance the impression of your qualifications.

To stay up-to-date with the latest industry regulations and standards, I actively participate in professional organizations, such as the American Society for Quality (ASQ) and attend relevant conferences and workshops. I also subscribe to industry newsletters and journals to keep abreast of changes in legislation and best practices, ensuring my knowledge is current and applicable.

Certainly! In my previous position, I led a project to implement a comprehensive QMS compliant with ISO 9001. This involved developing policies, performing staff training, and conducting internal audits. As a result of the project, we achieved certification within the expected timeline, and our lab saw a 20% reduction in non-conformities, showcasing a significant improvement in our quality practices.

A successful Quality Assurance Lead should possess strong analytical and problem-solving skills, excellent communication abilities, and a deep understanding of regulatory standards. Additionally, adaptability, attention to detail, and the ability to collaborate with diverse teams are essential qualities that drive the success of quality assurance processes.