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.
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
Company Benefits & Perks
Generous equity at an early stage company
Robust medical, dental and vision benefits
4x daily Shuttle bus to & from San Francisco (more locations to come)
Fully stocked kitchen and snacks
Free catered lunches and dinners
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.