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Quality Assurance Specialist (Equipment Oversight)

synthego · 30+ days ago

Redwood City, CA

$73k+
Estimation

Full-time

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This position is responsible for oversight of GMP/GLP equipment qualification, which includes introduction of new GMP/INDe equipment, modifications to existing equipment. Provides technical expertise on Quality Assurance standards and processes.

What You'll Do:

Lead and manage initiation of Qualification protocols(IQ, OQ, PPQ) for GMP and GLP.
Lead Equipment Management and Ensure all GMP/GLP equipment preventive Maintenance and/or Calibration activities including scheduling and documentation.
Support and work closely with Equipment, software and other system vendors to ensure Maintenance activities are scheduled in a timely manner.
Lead and manage investigation of Equipment failure reports (Deviations) and Change controls
Support Computer System Validations by authoring Test cases and performing executions.
Lead and manage validation/qualification status for GMP equipment, facilities and utilities.
Ensure equipment and systems are labeled with their qualification and calibration information and Update equipment and system information accordingly in QMS and Equipment Management Databases.
Responsible for revising equipment management SOPs and Validation Master Plans based on the outcome of the validation activities.
Identifies, classifies and reports deviations, as appropriate and provides QA oversight of deviations and CAPA
Ensure all the execution activities are done per Good Documentation/Manufacturing practices.

About You:

Requires Bachelor’s or Master’s degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology)
Requires 3+ years of experience of Quality or Validation experience
GMP experience from Pharma/Biotech/Consumer Goods industries
Experience working with CMMS/EMS systems and QMS system
Strong attention to detail
Good collaborative and team oriented skills to work well with the rest of the organization
Ability to think on one's feet and change direction easily to accommodate the situation at hand

Company Perks & Benefits

Generous equity
Medical, dental, and vision benefits
401k Program
Subsidized catered lunches and dinners with a fully stocked kitchen & snacks
Onsite Gym
Daily 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.

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Last updated on Aug 30, 2023

About the company

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synthego

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