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.
The responsibilities of this position include performing quality assurance activities that support Good Manufacturing Practices (GMP) related to clinical Drug product and Packaging 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:
• Audits contract manufacturer drug product fill finish batch records and resolving more routine issues independently, but raising more significant concerns or issues with a Sr. QA Specialist or the supervisor. Prepares audit reports and communicates any critical or major issues to QA Management and end users.
• 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 batch release data and Certificate of Analysis (CoA) for clinical drug product in preparation for final release approval by senior level QA team member.
• Reviews QC generated analytical data to ensure appropriate test QC specifications were followed. Provides report of findings to senior level staff.
• Assists with investigations when manufacturing or testing deviations occur to ensure compliance with related specifications and requirements. Participates 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.
• Reviews packaging and labeling batch records and label for clinical trial materials. Ensures compliance issues were appropriately investigated and resolved; when necessary bring proposed solutions to QA management for guidance.
• Performs 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
• Maintains tracking for lot release and packaging and labeling of clinical trial material.
• Conducts 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.
• 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.
• 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 assigned
Education & Credentials
Bachelor’s degree in life sciences with a minimum of 5 years of experience in the Quality area in a GMP regulated manufacturing facility
• Experience performing external quality audits
• Experience writing comprehensive audit reports, and SOPs
• Experience performing fill finish/drug product manufacturing batch record reviews
• Experience conducting training on SOPs or GMP regulations
Knowledge, Skills and Abilities
• Is capable of working with little supervision and is expected to be fully independent when performing routine tasks.
• Strong writing skills and attention to details
• 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 once
Certification as Quality Auditor a plus.
Experience with electronic learning and quality management systems a plus
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 email@example.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
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