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QC Analyst II – Environmental Monitoring

QC Analyst II – Environmental Monitoring

Quality Control
Job Location 
Regular Full-Time

More information about this job


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

Summary of Position 

This position is responsible for performing activities in support of the microbiology and environmental monitoring testing programs including monitoring of the manufacturing cleanrooms. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.


Responsibilities and Job Duties:

  • Collects routine environmental monitoring (EM) samples and water samples on a daily basis in accordance with all protocols and procedures.
  • Conducts microbiology testing such as Bioburden, Endotoxin, and TOC for raw materials, in-process, and final formulation samples in accordance with standard operating procedures.
  • Conducts plate enumeration and microbial identification as needed.
  • Enters and reviews data into laboratory data system to ensure data integrity and adherence to standard operating procedures and GMPs.
  • Ensures lab equipment is calibrated and maintained as required for testing per standard operating procedures.
  • Reports “out of specification” results from sampling and testing to supervisor and assists with performing laboratory investigations.
  • Revises and updates standard operating procedures, as needed.
  • May perform special projects related to problems encountered with microbial testing and instruments, and make recommendations for solutions that will minimize future issues.


Education & Experience

  • High School Diploma and minimum of four years of experience in performing Environmental Monitoring and Microbiology testing.
  • Bachelor’s Degree in a scientific discipline and minimum of two years’ related experience
  • Experience in one or more of the following areas required: Environmental Monitoring, Quality Control, Microbiology, and/or GMP production.


Knowledge, Skills and Abilities

  • Working knowledge of good laboratory practices.
  • Ability to work independently on assigned methods and follow procedures.
  • Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.
  • Ability to resolve problems independently and responsively.
  • Be able to work in a team environment in a cooperative and respectful manner.
  • Ability to stand for periods of time when performing tasks on the floor.
  • Ability to work a varied schedule including off shift and weekends.
  • Ability to lift up to 50 pounds.


Supervisory Responsibilities




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 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.