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Quality Assurance Specialist III

MacroGenics

This is a Full-time position in Rockville, MD posted March 1, 2021.

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.Summary of PositionThe responsibilities of this position include performing quality assurance activities that support Good Manufacturing Practices (GMP) related to clinical lot release, ensuring strict compliance within MacroGenics and our external vendors. He/she will interface with other departments and will provide guidance, make recommendations and in some cases, resolve a variety of GMP and other quality issues that arise.Responsibilities and Job Duties:* Performs audits of executed manufacturing batch records and resolves routine issues independently, but raising more significant concerns or issues with a Sr. QA Specialist or the supervisor. May participate in cross-functional teams to conduct risk analysis, as needed, to identify root causes for process and system failures, and analyze changes under consideration.* Reviews quality control batch release data for clinical in preparation for final release approval by senior level QA team member.* Assists with investigations when manufacturing or testing deviations occur to ensure compliance with related specifications and requirements. Participate on a team focused on determining what went wrong, how to prevent the problem in the future, and determine whether the impacted product is suitable for release. Raises issues and concerns to next highest level to decide how to proceed.* Performs internal audits of systems and manufacturing processes to ensure they are working properly and effectively to maximize the success of a product release.* Conducts internal and external supplier audits to ensure that our vendors meet our quality requirements. Follows up with any deficiencies or concerns with vendors and/or audit results with sr. personnel. Writes audit reports summarizing findings, any concerns or issues and recommendations for remediation or improvement, and brings failures to senior quality management for final action and decisions.* Performs clinical lot release activities ensuring all steps in the process met the required specifications for final review by senior level staff member. Will raise any specific concerns and recommendations* Reviews QC generated analytical data to ensure appropriate test methodology and other QC specifications were followed. Provides report of findings to senior level staff.* Conducts initial GMP employee training with new hires. Works with supervisor to ensure training is effective and determines if additional or refresher training is needed and administers when necessary* Writes, reviews, and approves deviations in the electronic quality management system ensuring they meet all required specifications. Analyzes any incidents that occurred including the cause, the solution, and preventive measures. Brings non routine issues to the attention of senior personnel.* Reviews and approves products and materials ensuring that the right material is ordered and tested and that they are in line with USP and other specifications.* Prepares new and revises existing SOPs for final review and approval by senior staff.* Maintains a high standards of ethics, honesty and urgency required to meet the quality standards, objectives and goals.* Performs other QA duties as assignedQualificationsEducation & CredentialsAssociates’ degree in biotechnology or a related life sciences field of studyExperience* A minimum of 4 years of experience in quality assurance, manufacturing or a related regulated function in the pharmaceutical industry in a GMP manufacturing facility* Two years of experience in a QA role in the pharmaceutical industry* Experience performing internal and external quality audits* Experience writing comprehensive audit reports, and SOPs* Experience performing batch record reviews* Experience conducting training on SOPs or GMP regulationsKnowledge, Skills and Abilities* Demonstrated ability to with little supervision and is expected to be fully independent when performing routine tasks.* Strong writing skills* Ability to understand why a process or procedure is required and how it fits into the bigger picture* Must have excellent interpersonal and communication skills and be able to work well within teams* Strong problem-solving skills but also an understanding of when to raise the issue to the next level* Proficiency with MicroSoft Office software: MicroSoft Word, Excel and PowerPoint.* Demonstrated ability to manage conflict* Must be able to manage multiple projects effectively at onceSupervisory ResponsibilitiesNonePreferred QualificationsCertification as Quality Auditor a plus.Experience with electronic learning and quality management systems a plusStatementMacroGenics 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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.Equal Opportunity Employer/Veterans/Disabled

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