Quality Control Specialist - Crisprevolution

Synthego Redwood City , CA 94063

Posted 6 months ago

The Quality Control Specialist will join our quality team to be a key player in all scientific and documentation aspects of product development, release, stability, and investigations in support of maintaining and improving processes within CRISPRevolution. This role will report into the Quality Control Manager.

What You'll Do

  • Provide guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.

  • Provide guidance to test methods, equipment acquisition, sample plan definition, and validation development.

  • Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards.

  • Document, analyze, and interpret QC and experimental data.

  • Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.

  • Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.

  • Manages development or transfer of new QC processes or improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software.

  • Conducts experimentation in the synthesis, characterization, and/or functional integrity of oligonucleotides or Raw Materials.

  • Develops equipment and process validation plans related to QC.

  • Recommends testing for manufacturing-related non-conformances and CAPAs.

  • Management of contract testing labs for in-process and final release assays.

About You

  • Ability to identify customer needs and issues and develop realistic solutions to meet needs and solve problems.

  • Ability to communicate recommendation and decisions across the organization.

  • 3+ years in a regulated environment or similar

  • Knowledgeable in statistical analysis and design of experiments.

  • Minimum of Bachelor's Degree in a scientific discipline or equivalent experience.

  • Possess working knowledge of cGMP

  • Strong communication skills

  • High degree of attention to detail

  • Experienced with analytical method development and validation preferred.

  • Analytical instrumentation experience preferred (e.g. ESI-MS, LC-MS, HPLC, ddPCR, bioburden testing, endotoxin testing, etc.)

Nice to Haves

  • B.S. Chemistry or Biochemistry

Company Benefits & Perks

  • Competitive salary

  • Generous equity at an early stage company

  • Robust medical, dental and vision benefits

  • 401k Plan

  • 4x daily Shuttle bus to & from San Francisco (more locations to come)

  • Fully stocked kitchen and snacks

  • Free catered lunches and dinners

ABOUT SYNTHEGO

Synthego's vision is to turn biology into an information science, with the ultimate goal of dramatically extending the healthy human lifespan.

Synthego builds advanced bioinformatics and automated hardware platforms to create next-generation molecular biology tools, starting with full-stack genome engineering.

These world-class tools accelerate basic scientific discovery, critical disease cures and novel synthetic biology applications to improve and prolong life.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Quality Assurance Specialist

Synthego

Posted 2 weeks ago

VIEW JOBS 9/26/2019 12:00:00 AM 2019-12-25T00:00 Synthego is searching for a Senior Quality Assurance Specialist to join our team and help create the world's first fully automated cloud-enabled lab. The perfect candidate would thrive in a fast paced, dynamic environment. You will have a player-coach mentality with the ability to adapt to changing requirements and priorities. Possessing the ability to partner with cross-functional leaders to exact change and drive continuous improvement is a must. What You'll Do * Performs Drug Substance Final Product Release including batch record review and analytical data review. * Collaborate with cross-functional teams to implement robust Corrective and Preventive Actions (CAPA). * Review and approve change controls as appropriate. * Review and approve project lifecycle documentation including commissioning and validation packages. * Represents Quality in site equipment, facility, utility and laboratory systems projects. * Identifies compliance gaps, recommends process improvements, and proposes changes. * Supports internal and regulatory audits/inspections as required. * Participates in authoring or revising Standard Operating Procedures (SOPs) to ensure compliance and quality objectives are met. * Assist with implementation and management of various quality systems including, but not limited to, Deviation Management, Nonconformance Management, CAPA Management, Validation Master Plan, Risk Management and Change Control in a GMP and RUO manufacturing environment. * Present and defend Quality records and data packages during external customer or Regulatory inspections. * Participates in Material Review Board meetings and product dispositions as applicable About You * 6+ years of relevant experience in a life science company with increasing levels of responsibility. * Minimum of Bachelor's Degree in an Engineering discipline or equivalent experience, Masters preferred. * Possess working knowledge of cGMP, ICH Q7, ICH Q10 Possess working knowledge of Quality Management Systems (QMS), processes, and procedures. * Experience in Biotech or Biopharmaceutical environment required. * Strong user of excel or statistical programs. * Familiarity with problem-solving, root cause analysis tools, impact assessment, and CAPAs. * Experience with QMS software platforms. Experience with Arena Solutions PLM is a plus. * High degree of attention to detail. * Strong documentation skills.Responsible and accountable with non-compromising high ethical standards. Company Benefits & Perks * Competitive salary * Generous equity at an early stage company * Robust medical, dental and vision benefits * 401k Plan * Fully stocked kitchen and snacks * Free catered lunches and dinners * 4x daily Shuttle bus to & from San Francisco ABOUT SYNTHEGO Synthego's vision is to turn biology into an information science, with the ultimate goal of dramatically extending the healthy human lifespan. Synthego builds advanced bioinformatics and automated hardware platforms to create next-generation molecular biology tools, starting with full-stack genome engineering. These world-class tools accelerate basic scientific discovery, critical disease cures and novel synthetic biology applications to improve and prolong life. Synthego Redwood City CA

Quality Control Specialist - Crisprevolution

Synthego