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Quality Control Supervisor, Microbiology

Quality Control Supervisor, Microbiology

ID 
2017-1102
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

The Quality Control Supervisor, Microbiology is responsible for overseeing the daily operations of the microbiology and environmental monitoring testing programs at MacroGenics to ensure compliance with cGMP standards. This position will directly supervise a team of QC analysts, and will interact extensively with other department supervisors, quality personnel, manufacturing personnel, and business partners. This person will also be responsible for development, transfer and validation of microbial test methods.

 

Responsibilities and Job Duties:

  • Oversees the work of QC analysts that contribute to the Supervisor’s area(s) of functional responsibility, ensuring all work is completed properly and in a timely manner. Provides input and feedback to other supervisors for ongoing development of employees and towards annual performance assessments.
  • Provides direct supervision of one or more junior level QC analysts, assuming primary responsibility for communication of requirements and expectations of the employee’s daily job. Will perform all aspects of a supervisor’s role including hiring, coaching, developing, providing regular feedback to employee about his/her performance, and managing performance or behavioral deficiencies.
  • Manages Microbiology (Environmental Monitoring and utilities) related sampling and testing of in-process and lot release samples. Functional area oversight requires assuring that relevant deliverables are provided on time to support corporate, CMC, and departmental goals. Will also be responsible for assuring that analysts are trained on the relevant equipment and methodology, assuring equipment is maintained and used properly, providing first line troubleshooting as needed, and reviewing related Quality event records (e.g., Deviations and CAPAs).
  • Assists in designing and continuously improving Quality Control systems, particularly within areas of microbiology.
  • Writes and reviews departmental and interdepartmental SOPs covering microbial methods and general policies.
  • Reviews, analyzes and trends microbial data that may include EM, in-process, lot release, and/or stability related microbial testing. Regularly review failure trend data within assigned functional area, and be responsible for investigation of out of trend situations. 
  • Responsible for developing, establishing, transferring, and validating microbial testing methodology.

Qualifications

Education, Experience, & Credentials

  • High School Diploma and minimum of 15 years of direct related experience, plus minimum of 5 years of supervisory experience.
  • Bachelor’s Degree in a scientific discipline and minimum of 8 years of experience.
  • Significant experience in a GMP or GLP testing environment.
  • Prior experience coaching, mentoring or supervising junior level laboratory personnel.
  • Prior experience providing oversight of a cleanroom microbial area of expertise, such as environmental monitoring or utilities monitoring group.
  • Experience working on extremely complex problems in which analysis of situation or data requires an in depth evaluation of intangible variables.

Knowledge, Skills and Abilities

  • Ability to act independently to determine schedules, methods and procedures on new assignments
  • Possesses the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
  • Able to handle multiple priorities in a fast-paced environment
  • Excellent written and verbal communications skills
  • Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
  • Broad knowledge base of cGMP requirements for quality control testing
  • Flexibility and adaptability to facilitate the movement into different areas of QC 
  • Proficient in the use of Microsoft or equivalent software; word processing, email, spreadsheet or other analysis tools, database, and Internet

Supervisory Responsibilities:
Will directly supervise the activities of 2-6 lower-level personnel.

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.