Job Description
This position is responsible for oversight of GMP equipment qualification, which includes introduction of new GMP equipment, modifications to existing equipment, and computer system validation (CSV) in Manufacturing and Quality control.
- Provides technical expertise on Quality Assurance standards and processes.
- Ensures compliance and providing QA oversight of Fremont site equipment qualification according to cGMP regulations for clinical and commercial products.
- Implements continuous improvement efforts as it relates to equipment activities.
What You'll Do
- Review and approval of equipment qualification and CSV procedures to ensure compliance with cGMP requirements
- Supports regulatory audits, internal audits and customer audits
- Participate in audits as SME, prep room staff or Inspection room staff
- Collaboration on responses to any observations
- Oversight and approval of equipment qualification and CSV activities
- Review and approval of change controls, protocols, reports, user requirements, CP-11 assessments, recipe specifications, test cases, and P&IDs
- Identifies, classifies and reports deviations, as appropriate and provides QA oversight of deviations and CAPAs
- Works closely with others to determine root cause and potential preventative/corrective actions
- Ensures support for the timely closure of investigations
About You
- Requires a Bachelor’s degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology) or Engineering with five (5) years Quality or Validation experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility
- Related work experience executing or overseeing equipment qualification in a cGMP environment
- Experience in Quality systems such as Deviations or Change Control
- Expertise in Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to equipment qualification in a clinical and commercial environment
- Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function
- Overall understanding of Quality Assurance specifications and process
- Ability to communicate in an open, customer-focused manner
- Ability to influence in a team environment and collaborate with peers
- Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented
- Ability to interpret and relate Quality standards for implementation and review to functional areas
- Ability to work effectively on problems of diverse scope, with analysis/evaluation of data
- High level of personal motivation and initiative, and ability to work independently on projects
- Attention to detail, safety, quality and customer requirements
- Proficiency with MS Office products (specifically Word, Outlook, PowerPoint and Excel)
About Us
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.
