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QC Analyst I - Environmental Monitoring

QC Analyst I - Environmental Monitoring

ID 
2018-1135
Category 
Quality Control
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

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 and performs plate enumeration on a daily basis in accordance with all protocols and procedures.
  • Performs basic water testing such as pH and conductivity in accordance with standard operating procedures.
  • Enters sampling and testing data into laboratory data system, and ensure adherence to standard operating procedures and cGMPs. 
  • Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
  • Reports out of specification results from the sampling and testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
  • Revises and updates standard operating procedures, as assigned with guidance from senior analysts and/or supervisor. 

Qualifications

Education & Experience

  • High School Diploma and minimum of one year experience in performing Environmental Monitoring and Microbiology testing. 
  • Bachelor’s Degree in a scientific discipline

Knowledge, Skills and Abilities

  • Working knowledge of good in performing Environmental Monitoring or Microbiology testing. 
  • Needs to be able to follow directions that are outlined in SOPs and other quality guidelines.
  • Ability to organize daily activities to meet internal customer needs in a fast-paced environment
  • Ability to understand when he/she should seek advice and guidance
  • Data entry skills 
  • 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
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.