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Sr. QA Specialist

Sr. QA Specialist

ID 
2018-1198
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 and overseeing quality assurance activities that support all QA aspects of the drug substance release process for clinical and future commercial batches.. The incumbent in this role will review, evaluate and approve all GMP data supporting various MacroGenics programs. As the lead, the incumbent will oversee the timely review and release of the GMP batches manufactured in MacroGenics commercial facility, and will communicate with members of quality assurance and quality control regarding any concerns impacting lot release upon data review. The incumbent will also ensure that quality systems supporting batch release are compliant with internal procedures and regulations.


Responsibilities and Job Duties:

  • Leads, coordinates, and performs lot release of batches manufactured in the commercial facility.
  • Audits executed manufacturing batch records and resolves routine and more complex issues independently. Raises significant concerns or issues with a QA manager. May facilitate cross-functional teams to conduct risk analysis, as needed, to identify root causes for process and system failures, and analyze changes under consideration. Reviews and approves quality control batch release data for clinical and future commercial batches by ensuring appropriate test methodology and other QC specifications were followed. 
  • Drives investigations when manufacturing or testing deviations occur to ensure compliance with related specifications and requirements. Coordinates 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, issues and recommendations for remediation or improvement, and brings failures to senior quality management for final action and decisions.
  • Conducts external supplier audits to ensure that our vendors meet our quality requirements. Identifies deficiencies or concerns with vendors and/or audit results and makes recommendations for corrections. Writes audit reports summarizing findings, issues and recommendations for remediation or improvement, and brings failures to senior quality management for final action and decisions.
  • Conducts quality system training. Works with supervisor to ensure training is effective and determines if additional 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 significant issues or problems that can’t be resolved to the attention of senior personnel. 
  • Reviews new and revises existing SOPs for final approval by senior staff. 
  • Maintains a high standard of ethics, honesty and urgency required to meet the quality standards, objectives and goals. 
  • Provides training, coaching and mentoring to junior level QA specialist and provides assessment and ongoing feedback to manager.
  • Performs other QA duties as assigned.

Qualifications

Education & Credentials

 

  • Bachelor’s degree in a related field of life science

Experience

  • A minimum of 8 years of experience in the Quality area in a GMP regulated manufacturing facility
  • Experience performing internal and external quality audits
  • Experience writing comprehensive audit reports, and SOPs
  • Experience performing batch record reviews
  • Experience performing batch release
  • Experience conducting training on SOPs or GMP regulations

Knowledge, Skills and Abilities

  • Ability to handle multiple priorities and interface with individuals of Manufacturing, QC, group, project management and regulatory affairs.
  • Capable of working with little supervision and is expected to be fully independent when performing routine tasks.
  • Demonstrated ability to manage conflict 
  • Demonstrates good communication skills with others, and a willingness to teach others and show appreciation
  • Possesses a strong level of self-awareness 
  • Excellent organizational skills and attention to detail.
  • Individual must possess the ability to influence without direct authority.
  • Ability to understand why a process or procedure is required and how it fits into the bigger picture 
  • Must have excellent interpersonal skills and be able to work well within teams and possess the desire to work cross-functionally with diverse employees and external users in a cooperative and friendly manner. 
  • 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.
  • Must be able to manage multiple projects effectively at once
  • Must be able to plan activities to meet timelines and work from a Microsoft project schedule

Supervisory Responsibilities

None

 

Preferred Qualifications

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