Quality System Specialist / Manager
This individual will work directly with validation project scientists, manufacturing personnel and the management to assure the implementation of quality management. The primary responsibilities for this position are:
1) transfer of product specifications from development stage to manufacturing under FDA Quality System Regulation;
2) working with ISO certification agency to complete ISO13485 certification for IVD business and
3) supporting the maintenance and integration activities related to the Quality Systems, providing assistance with internal, customer and regulatory audits, and identifying opportunities for and implementation of continuous improvement. This individual may manage some operation related projects.
This individual should have experience in quality management system such as US FDA QSR (21 CFR: 820) or ISO 13485. This individual should be familiar with IVD immuno-assay product development process such as design control and IVD product manufacturing. Understand of immunohistochemistry (IHC) products for anatomic pathology application is a plus.Required Skills and Abilities
BS or MS or in relevant scientific field with minimum 3 years of industrial working experience under ISO 13485 or FDA QSR is desired.
Epitomics, Inc. is a biotechnology company dedicated to developing breakthrough monoclonal antibody technology for research and diagnostic applications. The Company's core technology is its unique and proprietary RabMAb®(Rabbit Monoclonal Antibody) technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays. Epitomics has also developed a proprietary method for humanizing RabMAbs called Mutation Lineage Guided (MLG) humanization. Epitomics, Inc. is headquartered in Burlingame, California.
To apply to the position: email your resume to firstname.lastname@example.org
No phone calls please.
NOTE: Epitomics is an Equal Opportunity Employer. There is no sponsorship available for this position. To comply with the Immigration Reform and Control Act 1986, Epitomics, Inc. requires that all employees provide proof of their identity and eligibility to work in the United States on their first day of employment in conjunction with completing the I-9 form.