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QC Analyst III - Environmental Monitoring

QC Analyst III - Environmental Monitoring

ID 
2017-1103
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 guide and partner with lower level QC analysts and provide ongoing feedback and information to the QC supervisors to ensure accurate documentation, timely completion of all EM and microbiological related testing, and timely review of data, while adhering to standard operating procedures and 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. 
  • Reports “out of specification” results from sampling and testing to supervisor, and initiates and monitors progress of microbiology investigations.
  • Ensures lab equipment is calibrated and maintained as required for testing per standard operating procedures. 
  • Identifies microbiology data trends and reports findings and provides recommendation to supervisors for review and consideration. 
  • Performs special projects related to problems encountered with microbial testing and instruments, and makes recommendations for solutions that will minimize future issues. 
  • Participates development, transfer and validation of microbial testing methods. 
  • Revise and update standard operating procedures as needed.
  • Mentor lower lever analysts, as needed. 

Qualifications

Education, Experience, & Credentials

  • High School Diploma and minimum of 8 years direct related experience
  • Bachelor’s Degree in a scientific discipline and minimum of 5 years 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. 
  • Good understanding of GMPs and have previous experience working within highly regulated pharmaceutical /biotech facilities.
  • Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.
  • 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.
  • Demonstrating ability to coach and train others. 
  • 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.