Quality Control Analyst I/II (Environmental Monitoring)

US-MD-Rockville
Requisition Number
17-989
Category
Quality Control
Type
Regular Full-Time

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 QC Analyst I/II (EM) is responsible for conducting quality control testing primarily in the area of environmental monitoring and microbiological testing.  This individual will be required to complete the testing in a timely manner while adhering to standard operating procedures and under GMPs.  The role also requires timely and accurate documentation and reporting of results to ensure compliance.

 

Responsibilities and Job Duties:

  • Perform routine environmental monitoring (EM), microbiology testing, water sampling, and microbial identification as needed to support manufacturing of clinical product.
  • Conduct routine and non-routine analyses of raw materials and in-process and finished formulations according to standard operating procedures as needed.
  • Participate in calibrating and maintaining lab equipment.
  • Participate in the preparation of investigations, summaries, and reports.
  • Review data obtained for compliance to specifications, and report abnormalities.
  • Revise and update standard operating procedures, as needed.
  • May perform special projects on analytical and instrument problem solving.

Qualifications

Education

Bachelors Degree in a scientific discipline

 

Experience

QC Analyst I

  • No previous experience required
  • Preference for experience working in a GMP/GLP environment

QC Analyst II

  • Minimum of two years of related experience
  • Experience working in a GMP or GLP environment

Knowledge, Skills and Abilities

QC Analyst I

  • Working knowledge of scientific principles
  • Ability to work flexible hours, including possible overtime and weekends

QC Analyst II

  • Working knowledge of scientific principles
  • Ability to work on extremely complex problems in which analysis of situation or data requires an in‑depth evaluation of intangible variables
  • Ability to act independently to determine methods and procedures on new assignments
  • Demonstrate the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
  • Experience in one or more of the following areas required: Environmental Monitoring, Quality Control, Microbiology, and/or GMP production
  • Ability to work flexible hours, including possible overtime and weekends

Preferred Qualifications

  • Environmental Monitoring and/or water sampling experience preferred.
  • Experienced performing any of the following test methods: Bioburden, Endotoxin, TOC, and Gram staining.

Supervisory Responsibilities

None

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.

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