Quality Assurance Specialist (Change Control Management)
Redwood City, CA, USA
Posted on Thursday, August 10, 2023
Synthego is searching for a Quality Assurance Specialist to join our team and help create the world’s first fully automated cloud-enabled lab.
As a QA Specialist for Change Control Management, you will play a critical role in ensuring the quality and compliance of changes introduced within the organization's processes, systems, and products. Your primary responsibility will be to oversee and manage the change control process to ensure that changes are properly evaluated, documented, approved, and implemented while adhering to regulatory standards and internal quality standards.
What You'll Do:
- Change Control Process Management:
- Develop, implement, and maintain the change control process in alignment with relevant regulatory requirements (e.g., FDA, ISO) and company policies.
- Collaborate with cross-functional teams to ensure changes are properly assessed, documented, and approved before implementation.
- Review and evaluate change requests to determine their impact on quality, safety, and compliance.
- Monitor the progress of change requests and ensure timely execution of approved changes.
- Risk Assessment and Mitigation:
- Conduct risk assessments for proposed changes to identify potential quality, regulatory, and safety risks.
- Collaborate with relevant stakeholders to develop risk mitigation strategies and contingency plans.
- Ensure that risk assessments are well-documented and communicated to relevant parties.
- Collaboration and Communication:
- Interface with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to facilitate effective change control processes.
- Communicate change control status, issues, and resolutions to management and stakeholders.
- Provide training and guidance to employees on change control processes and requirements.
- Quality Agreement:
- Collaborate with cross-functional teams to define and document quality requirements for partnerships, contracts, and agreements.
- Draft and review quality agreements to ensure alignment with regulatory requirements, industry standards, and company policies.
- Audits and Inspections:
- Participate in internal and external audits and inspections related to change control activities.
- Ensure that all change control-related documentation is readily available and compliant during audits.
- Bachelor's or Master’s degree in a relevant scientific or engineering discipline.
- 3+ years of experience in Quality assurance, change control, Operations or a related field within a regulated industry (pharmaceuticals, medical devices, biotechnology, etc.).
- Strong understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485) and quality management principles.
- Excellent organizational skills with meticulous attention to detail.
- Strong communication and interpersonal skills to effectively collaborate with diverse teams.
- Problem-solving and critical-thinking abilities to assess risks and develop appropriate solutions.
- Proficiency in document management systems, quality management software, and Microsoft Office Suite.
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.