10x is seeking a QA engineer II to establish, maintain and improve the product quality, compliance and processes to assure compliance with company policies, international standards and applicable regulatory requirements. This position works indirectly and directly with multiple functions and global quality to assure effective implementation of quality processes and drive continuous improvements.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating across the organization and with external partners, and provide immediate contribution.
What you will be doing:
- Ensure Product Compliance:
- Develop and maintain processes to ensure compliance with applicable regulatory requirements and ISO standards related to consumables, assays, and other products
- Generate and maintain product Safety Data Sheets (SDS) in accordance with regulatory requirements
- Understanding of Occupational exposure limits (OELs), Derived No-Effect Level (DNEL) and waste disposal of reagent and chemicals
- Manage Quality Operations:
- Investigate and resolve product quality issues, including nonconformances, deviations, and complaints related to consumables, assays, and other products
- Oversee corrective and preventive actions (CAPA), risk assessments, and change control processes
- Supplier Quality Management:
- Conduct supplier evaluations, performance monitoring, and supplier audits
- Manage material qualifications and follow up on supplier-related quality issues to ensure consistent product quality
- Other Responsibilities:
- Track key quality metrics and drive continuous improvements and preventive action programs
- Support internal and external audits
- Perform additional duties as assigned by management to support the company’s compliance and quality objectives
Minimum Requirements:
- A master’s or bachelor’s degree in biology, chemistry or science discipline, coupled with 2+ years (MS) or 5+ years (BS) of Quality Assurance experience in a manufacturing environment for Life Sciences or Pharmaceutical /Medical Device industry.
- Competent analytical and problem-solving skills
- Competent collaboration and communication skills with colleagues and external collaborators
- Proficient with data analysis tool
Preferred Skills and Experience:
- Experience with generating and maintaining product Safety Data Sheets (SDS) in accordance with regulatory requirements
- Experience with quality and statistical analysis tools (For example. Risk Analysis, FMEA, DOE, SPC, Six Sigma)
- Good understanding of Next Generation Sequencing (NGS) technology, along with proficiency in fundamental biological assays and tools, including qPCR and fragment analysis
- Hand on experience with electronic PLM, ERP, MES and enterprise Quality System tools
- Quality certification desirable (e.g. CQM, CQE, CQA, RAC)
- Experience with ISO9001 or ISO 13485 quality systems in a Quality Assurance role
About 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
