Quality Assurance Manager I
Job Title: Quality Assurance Manager I
Location: San Diego, CA 92127
Job Type: Full Time
Job Description:
GeneGoCell focuses on providing top-quality, innovative and fast-turnaround customized compliant (GxP, CLIA, ISO/IEC17025) services in Next-Gen Sequencing (NGS) and Flow Cytometry. With a team of talented scientific and compliant souls, GeneGoCell brings the best to our clients.
This role of quality assurance (QA) manager will be required to manage a team to effectively and efficiently carry out various quality assurance tasks, including ensuring the quality and turnaround time of the GxP testing production at GeneGoCell.
Responsibilities:
- Report to QA head at GeneGoCell. Under supervision by the senior management, manage the development, assessment, and enhancement of comprehensive quality policies, procedures, and documentation to ensure alignment with regulatory mandates and organizational objectives.
- Supervise, manage and grow the QA team (including QA manager) to effectively and efficiently carry out various quality assurance programs and activities.
- Utilize, optimize and implement the organizational quality management system and monitor progress.
- Administers policies and programs ensuring that processes at GeneGoCell meet established quality standards and regulatory compliance and uphold all applicable regulatory, federal, state, clients’ quality requirements within the Company.
- Collaboration in cross-functional teams and provide clarity on compliant and regulatory matters, align quality and regulatory initiatives with organizational goals, and foster a culture of accountability and integrity throughout the Company.
- Organize, coordinate, conduct and manage internal and external audit or inspection processes: ensuring rigorous audit preparedness and prompt resolution of audit findings. Ensuring continued compliance with established quality standards, including but not limited to GMP, CLIA, GLP, ISO/IEC17025 and, ICH.
- Ensure accurate and thorough documentation and record-keeping practices in accordance with regulatory mandates and organizational protocols.
- Solicits internal and external feedback with the goal of continuous quality improvement and improving the quality in various processes and products at GeneGoCell.
- Responsibility for personnel actions including hiring, performance management, and termination with concurrence from HR & senior leadership.
Requirements:
- MS degree in biology or relevant scientific discipline with at least 4 years of industry working experience. Minimum of a BS degree in relevant discipline with at least 8 years of industry working experience.
- Credential/certification, e.g. CMQ/OE or equivalent. Or minimally, eligible to obtain such certification within 6 months since hiring.
- 1-2 years quality management experience in quality assurance or quality control department is preferred..
- In-depth knowledge and understanding of quality standards including, but not limited to, GMP, GLP, CLIA, CAP, ISO, FDA, EMA, NIST, ANAB and other relevant of regulatory or accreditation bodies.
- Management skills with attention to detail and a demonstrated ability to effectively manage various complex projects and initiatives.
- Proven management skills with a track record of effectively managing high-performing teams.
- Proficiency in navigating dynamic environments, meeting stringent deadlines, and thriving amidst high-pressure situations.
- Excellent communication skills, both written and verbal, coupled with the ability to cultivate collaborative relationships across diverse functional areas.
- Experience in conducting and managing internal and external audits, ensuring adherence to regulatory requirements and industry best practices.
- Ability to periodically present and report quality progress to the senior leadership team
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Vision insurance
- Paid time off
If you are interested in this position, please send your resume and relevant information to HR@GeneGoCell.com