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QA Specialist II

QA Specialist II

ID 
2018-1190
Category 
Quality Assurance
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

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 Position

The 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. He/she will interface with other departments and will consult with Sr. QA Specialist or the supervisor in order to provide guidance, recommendations and in some cases, resolve a variety of GMP and other quality issues that arise.


Responsibilities and Job Duties:

 

  • Audits executed manufacturing batch records and resolving more 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.
  • 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. 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. 
  • Reviews QC generated analytical data to ensure appropriate test methodology and other QC specifications were followed. Provides report of findings to senior level staff. 
  • 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. 
  • Review and verify training records. Ensure training has been complete for GMP employee who is conducting any manufacturing processes and QC testing. 
  • Release raw material based on the product specifications. 
  • Maintains a high standards of ethics, honesty and urgency required to meet the quality standards, objectives and goals. 
  • Performs other QA duties as assigned.

Qualifications

Education & Credentials

 

  • Bachelor’s degree in a related field of study

Experience

  • A minimum of two years of experience in the Quality area in a GMP regulated manufacturing facility
  • Experience performing internal quality audits
  • Experience performing raw material release 
  • Experience writing comprehensive audit reports, and SOPs
  • Experience performing batch record reviews

Knowledge, Skills and Abilities

  • Ability to work independently on routine tasks, requires general instruction/oversight for new projects
  • 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 once

Supervisory Responsibilities

None

 

Preferred Qualifications

  • Certification as Quality Auditor a plus.
  • Experience with electronic learning and quality management systems a plus
  • Experience with SAP system a plus

 

 

Statement

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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.