ImmunoReagents Hires Quality Assurance Manager for ISO Certification

Thursday, February 14th, 2019

Exporter of Exceptional Immunoassay Reagents is Pursuing ISO13485 Certification


ImmunoReagents announces the appointment of Roger Lee as the new Quality Assurance Manager.  Roger is bringing to the company, nearly 20 years of quality management experience and compliance from the biopharmaceutical development and production community.

As the QA Manager, Roger will be in charge of the quality functions that supports the manufacturing of antibodies and reagents and will work closely with Dr. Ann Black, CEO of ImmunoReagents in order to advance the company toward ISO 13485 certification.  With Roger’s close attention to detail, he will focus on strengthening ImmunoReagents’ current policies and procedures in addition to creating new ones, ensuring that the facility and team remains in compliance while striving to become ISO13485 certified.

Prior to joining ImmunoReagents, Roger received his B.S. in Biology from the University of Maryland and has worked at Diosynth Biotechnology, Grifols, and Catalent Pharma Solutions.  His previous experiences included quality control, technical review, document control, commercial and clinical manufacturing lot release, change control, QA validation, and supplier quality.  Roger’s has also been involved in numerous successful regulatory inspections including FDA, EMEA and Health Canada.

ImmunoReagents is happy to have Roger on our team.  “Roger has an extensive background of experience through quality and regulatory inspections that will help the company soar to ISO certification and help increase our customers within the diagnostic community” said Dr. Black.

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