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 assisting with administering the compliance programs at MacroGenics Inc. The individual will initiate and review documentation associated with compliance such as vendor questionnaires, vendor audit reports, vendor audit responses, change notifications, and product complaints. The individual will audit and qualify vendors according to MacroGenics internal procedures and ensure qualification statuses for all vendors are current. The individual will also conduct internal audits of the Quality Assurance department. The individual will drive resolution to issues or concerns, and communicate with quality assurance management and cross-functionally as necessary on a routine basis. This position will interface with various GMP departments such as quality control, manufacturing and supply chain on a frequent basis.
Responsibilities and Job Duties
Sr. QA Specialist will also perform the following responsibilities and duties:
QA Specialist III:
Sr. QA Specialist:
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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