Fluidigm South San Francisco , CA 94080
Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
Our life science analytical and preparatory systems in mass cytometry and genomics can be found in leading academic institutions, clinical research laboratories, and pharmaceutical, biotech and ag-bio companies worldwide. Our mission is bold and ambitious, powering advancements in human health research that can change lives.
Fluidigm is looking for a talented individual to prepare manufacturing deliverables for reagent operations. The Reagent Quality Engineer will work closely with the proteomic and genomic reagent manufacturing teams as well as other internal shareholders to drive timely resolution of reagent CAPAs. This is a 6-month contract with possibility of conversion to full-time, based in South San Francisco, California.
Work cross-functionally with QA, manufacturing and other stakeholders to implement appropriate corrective and preventative actions.
Perform thorough CAPA investigations to identify root cause, formulate appropriate action plans and execute them in a timely maner.
Perform detailed data analysis to support CAPA investigation
Be responsible for preparing and revising documentation to ensure compliance with good documentation practices and ISO13485:2016 requirements.
Represent manufacturing operations at CAPA review meetings
Maintain records and laboratory environment to comply with regulatory requirements, good laboratory practices, and standard operating procedures
Train manufacturing staff as needed to ensure effective and successful implementation of changes.
Enjoy a highly competitive compensation package, including better-than-average benefits and growth opportunities, as well as a dynamic and rewarding company culture
Have fun, be fully engaged and promise to have a life beyond "work"
S. degree in Biology, Biochemistry, or similar life science discipline required
Demonstrable experience performing CAPA investigations and implementation in an ISO13485 environment
Experience with ISO 13485:2016 highly preferred
Excellent organizational and communication skills (written and verbal) to effectively drive CAPAs to closure
Working knowledge of MS Office and a general understanding of ERP and PLM concepts
Sounds good? Apply online with your resume!
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, age, or national origin.