Bachelors degree or foreign equivalent degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, Biochemical Engineering or Mechanical Engineering and 10 years of relevant progressively responsible QA experience in a regulated environment.br br In the alternative, will also accept a candidate with a Masters degree or foreign equivalent degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, Biochemical Engineering or Mechanical Engineering and 8 years of relevant QA experience in a regulated environment.br br Experience, which may have been gained concurrently, must includebr 6 years of experience focused on Drug substanceDrug product quality.br 3 years of in plant QA experience.br 3 years of experience in the development of SOPs, controlled documents, and training courseware for cGMP GDP Quality Assurance.br 2 years of experience working with CMOsCDMOs.br br A qualified candidate for consideration should be an excellent communicator, who is goal and timeline driven, and is able to participate and work effectively on multiple cross functional teams. A qualified candidate for consideration will be expected to possess and demonstrate the following knowledge, understanding, ability and expertisebr strong knowledge of global cGMP GDP regulations and guidance;br working knowledge of ICHGxP regulations and expectations;br strong knowledge and demonstrated ability in the use of problemsolving tools such as Risk Analysis, Root Cause Analysis and FMEA;br strong knowledge of Drug substance and Drug product manufacturing and analytical testing;br strong technical expertise in QAQC, Manufacturing, and Supply Chain processes supporting development and maintenance of cGMP compliant quality systems; andbr Auditing of supplier manufacturingtesting sites for cGXP compliance.br br This is a virtual position within the continental U.S. and requires up to 10 domestic and international travel.br br br Note to Section C.1., Employers name The employers legal name was changed from EQRx, Inc. to EQRx International, Inc. following the submission of the Form ETA 9141, Application for a Prevailing Wage Determination in support of this permanent labor certification application. The companys FEIN 842846430 has NOT changed.br br br Note to Section I.c., Recruitment Information The recruitment advertisements were posted for EQRx International, Inc.s headquarters office location in Cambridge, MA. An additional recruitment advertisement was also posted in a national newspaper USA Today since the position is remotevirtual position and candidate may work remote from anywhere in the continental U.S.br br br Note to Section J.11.16., Education The alien in Section J holds a Bachelor of Pharmacy from Rajiv Gandhi University of Health Sciences Karnataka, in Bengaluru, India awarded in August of 2003 and a Master of Pharmacy Pharmaceutical Sciences from Rajiv Gandhi Unviersity of Health Sciences Karnataka, KLE Societys College of Pharmacy in Belgaum, India awarded in March of 2007; and a Doctor of Philosophy in Pharmaceutical Sciences from Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India awarded in February of 2017.

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