Quality Assurance Lead
San Diego Metropolitan Area
Summary of Role:
Codex DNA is seeking a Quality Assurance Lead who is a self-motivated individual and works well in a fast-paced environment for a growing biotech company. This individual will help drive, maintain, and improve Codex DNA’s and Eton BioScience’s internal and external QMS audits. The ideal candidate will have experience with Quality Management Systems, internal/external audit, deviation, and CAPA.
Essential Duties and Responsibilities:
- Support Eton Bioscience quality system to continue enforcement and implementation of ISO 9001:2015 in preparation for annual re-certification.
- Ensure compliance by routinely checking on tasks, forms, training logs, etc. that need to be documented and filed away in preparation for internal and external audits.
- Assist with design and implementation of new forms or processes that will aide in meeting requirements of ISO 9001:2015.
- Manage nonconformance, corrective action and complaint logs to ensure all issues are being logged and followed up on.
- Work alongside all departments to understand workflow and how different processes can affect quality.
- Assists with maintaining Qualified Supplier List by working with Purchasing
- Lead preparations alongside the ISO consultant for internal and external QMS audits, including regulatory bodies and clients.
- Assist with completing Customers’ request for Supplier Quality Questionnaires.
- Routinely assist in reviewing risk assessment logs, calibration logs, etc. to ensure compliance with ISO 9001:2015.
- Review SOPs and work alongside departments to ensure all SOPs are up to date in our document control system.
- Assist with collecting data to identify whether KPI goals are being met.
- All other duties related to ISO implementation and re-certification as assigned or necessary.
- 4-8 years of experience in progressive roles working with Quality Management Systems in a quality assurance or quality control function.
- 1-3 years of experience in inspection/audit readiness activities is highly preferred.
- 1-3 years of experience Biotech Service experience is a plus.
- Demonstrated ability to collaborate effectively with cross-functional teams, e.g., Process Development, Manufacturing, Quality Control and Technical Support.
- Self-motivated, hard-working, detail-oriented, and able to work in a fast-paced team environment with demonstrated problem-solving skills.
- Excellent time management skills and ability to work independently.
- Computer literacy using Microsoft Office Suite and LIMS systems.
- Excellent math skills, strong organizational skills, and strong communication skills.
- Take initiative and have a growth mindset.
- Ability to respond to and investigate quality issues.
- Prior experience in molecular biology techniques and sequence analysis is highly desirable.
- ISO 9001:2015 experience is a plus.
- Bachelor’s degree in molecular biology, biochemistry or related field is required.
- As a critical and essential role, the candidate must be willing and able to travel to the San Diego, CA office to report to work. We have protocols in place to provide a safe, socially distanced work environment.
- Prolonged periods of sitting at a desk and working on a computer.
- Ability to lift up to 15 pounds required.
Job type: FULL_TIME
Experience: 4 Year