MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
This position is responsible for reviewing, evaluating, and approving equipment, facility and utility related documentation such as validation protocols, change controls, out-of-tolerance reports, calibration and preventive maintenance records, repair work orders, SOPs, and for ensuring that GMP compliance has been met. This individual will be the point person for releasing all new systems into GMP use, and for withholding usage until requirements are met. The individual will drive resolution to issues or concerns, and communicate with the system owners on a routine basis. This position will interface with various GMP departments such as quality control, validation, facilities and manufacturing daily.
Responsibilities and Job Duties
Sr. QA Specialist will also perform the following responsibilities and duties:
Education & Credentials
QA Specialist III:
BS degree in a scientific, technical or engineering discipline with minimum 5 years of experience in Quality Assurance and/or Validation in a life science GMP regulated manufacturing facility.
Sr. QA Specialist:
BS degree in a scientific, technical or engineering discipline with minimum 8 years of experience in Quality Assurance and/or Validation in a life science GMP regulated manufacturing facility.
Knowledge, Skills and Abilities
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
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