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QC LIMS Administrator

QC LIMS Administrator

ID 
2018-1121
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 (QC) LIMS Administrator is responsible for ensuring the effective daily operation of the Laboratory Information System utilized by MacroGenics QC to support GMP testing. He/she will be responsible for maintaining user security, performing system maintenance, configuring new Master Data, troubleshooting, conducting training for new staff, and will be a liaison with other department staff, other departments, and external vendors.

 

Responsibilities:

  • Ensures LIMS is functioning properly so that QC and other personnel may access the system and complete necessary testing and review tasks.
  • Works with QC staff to configure Master Data for new products and new test methods, including Laboratory Execution System (LES) templates within the LIMS. Update Master Data as needed to ensure continued compliance and alignment with QC policies, product specifications, testing and stability protocols, and analytical methodology.
  • Maintains local user security by creating user profiles and setting access rights.
  • Assists with creating custom and/or adhoc reports and trend analyses using the LIMS capabilities.
  • Conducts training for new staff or new functionalities inside the company.
  • Works with IT to ensure correct database and system function, and troubleshoot as necessary.
  • Assists the company and appropriate staff during various audits and assessments of operations.
  • Assists in designing and continuously improving Quality Control systems, particularly within areas of software systems.
  • Writes and reviews departmental and interdepartmental SOPs involving LIMS.
  • Assists with review, analysis, reporting and trending of analytical data that may include environmental/utility monitoring, in-process, lot release, and/or stability related testing.
  • Participates in general QC laboratory functions including assuring equipment and software systems are maintained and used properly.

Qualifications

Education, Experience, & Credentials

  • Bachelor’s Degree in a scientific or technical discipline and minimum of 6 years of related experience, including at least 2 years of experience managing/administering a laboratory information management system in a GMP or GLP environment.
  • Working knowledge of QC laboratory operations.
  • Experience with change control and software validation

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 work on extremely complex problems in which analysis of situation or data requires an in depth evaluation of intangible variables
  • Able to handle multiple priorities in a fast-paced environment
  • Excellent written and verbal communications skills
  • Demonstrated ability to coach and train others
  • Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
  • Be able to work in a team environment in a cooperative and respectful manner
  • 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:
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.