Senior Qc Scientist

Job Title:Senior QC Scientist
Reports to: Associate Director, Quality Control
FLSA Class: Exempt

How this role drives the company forward:
The Senior QC Scientist is primarily responsible to perform quality control on complex products and instruments in compliance with all applicable regulations and ISO 13485 standards The position requires the ability to work collaboratively with a variety of internal cross-functional teams including R&D, Engineering, Manufacturing, Quality Assurance, Field Support, Planning, & Purchasing, and help external customer to develop OEM products. Strong communication and organizational skills are required to oversee the transfer of new products into the Quality Control workflow, resolve problems, improve processes, and manage QC stocks. The Senior QC Scientist is expected to use technical expertise to develop and document quality processes that support the R&D design & development and ensure the reliability and reproducibility of instruments and reagent products. This role must be a self-starter and quick learner who can provide immediate contributions. This role must excel at managing multiple projects and priorities and in communicating across multiple levels of the organization and customer.

The Senior QC Scientist is an on-site role located in San Jose, CA.

How you will make an impact:
In this role, you will work as part of the QC team and responsible for effectively managing the QC process of Reproductive Health Technology (RHT) and Next Generation Sequencing (NGS) product portfolio. You will play a key role in new product launch cycle, work with R & D and Marketing to identify operation requirements and ensure that quality testing deadlines are met. You will have an essential role in managing Takara’s Finished Goods custom business portfolio. The Senior QC Scientist’s excellent judgment and ability to troubleshoot issues quickly and effectively will help avoid interruptions in customers’ workflow which could one day lead to exciting scientific breakthroughs. We aim to find the best talent to join us and contribute to this exciting endeavor as a critical member of our QC team.

What will you do:

• Responsible for testing complex products, including instruments.
• Independently plans, schedules, and conducts experiments for one or more products or projects, exhibiting good skills in experimental design, data analysis, and record completion on time.
• Drive interactions and collaborations with the operations team to ensure products are stocked on time.
• Design or assist with the research on new methods and technologies to enhance QC testing procedures.
• Help R&D to launch new products on time. Communicate and manage information flow to ensure alignment on critical information within cross-functional groups.
• Review and track PLC projects to ensure quality tasks are completed on time.
• Identify risk management activities where possible and provide suggestions to mitigate risk.
• Prepare and present troubleshooting results or process improvement project reports in various forums to technical and non-technical audiences.
• Write work instructions and standard operating procedures related to product testing or quality control processes.
• Serves as a QC resource to R&D and other departments within the organization, including Product Management and Operations – especially during product launch and troubleshooting process.
• Lead CAPA projects (or work closely with Quality Assurance) related to product quality or non-conformities and investigate customer complaints.
• Participate in OEM customer meetings, and may represent the company in front of customers, e.g., Presenting troubleshooting or validation results summary.
• Assists with maintenance of laboratory equipment and troubleshoots problems, may act as liaison to equipment vendors to resolve problems.
• This position may have supervisory responsibilities.

How will you get here?

• Advanced degree in a scientific discipline with a strong background in molecular and cell biology, biotechnology, or biochemistry is required. Prior experience in Real Time & Single Cell instrument automation is a plus.
• Minimum 6 years of experience in a biotech or pharma with relevant work experience within a quality control team.
• Hands-on experience with NGS and DNA/RNA molecular biology is required.
• Very strong organizational, analytical, and problem-solving skills and attention to detail.
• Strong interpersonal and communication skills.
• Proficient in the use of computer programs such as Microsoft Office, FileMaker, Adobe Acrobat, and ERP system.

Job Type: Full-time

Pay: $140,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift

Work Location: In person