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Senior Quality Assurance Specialist

Company: Synthego Corporation
Location: Redwood City
Posted on: November 22, 2021

Job Description:

The Senior Quality Assurance Specialist will join our Quality team to be a key player in managing Batch record process, Supplier management process and Audit process at Synthego. What You'll Do

  • Continues to build on professional concepts toward culture of quality in compliance with ISO 9001:2015 standards and FDA regulations
  • Review and issue Batch record for production for GMP, GMP-Like and RUO
  • Perform Drug Substance Final Product Release including batch record review and analytical data review
  • Work cross-functionally with teams for preparing Drug substance batch record
  • Support Internal/External Audits
  • Manage and lead Supplier Management
  • Participate in revising and reviewing Standard Operating Procedures (SOPs) and Work instructions (WIs)
  • Participate in Validation/Re-Validation activities which includes Facility validation, Equipment validation and Process validation--
  • Assist in implementation of corrections, corrective actions and preventive actions as result of Deviations, Non-Conformances, CAPAs and Audit findings
  • Participate in improving Quality Management System--Prepare and present Quality metrics/records when required
  • Lead/Participate in new projects when required About You
    • Bachelor's degree and/or equivalent experience
    • 5+ years of experience in relevant field in the Medical Device/Pharma/Biotech
    • Working knowledge of FDA requirements and ISO 9001/13485 Standards
    • Strong problem-solving skills, team player
    • Strong verbal and written communication skills
    • Ability to work in a collaborative environment Company Perks & Benefits
      • Generous equity at a rapid growth company
      • Medical, dental, and vision benefits
      • 401k Plan
      • Free catered lunches and dinners with fully stocked kitchen & snacks
      • Onsite GymDaily
      • Shuttle bus to & from San Francisco
      • Paid parental leave
      • Flexible paid time off
      • Learning and Development resources 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.

Keywords: Synthego Corporation, Redwood City , Senior Quality Assurance Specialist, Other , Redwood City, California

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