Quality Systems Specialist
Rockville, MD

Job Description

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 Systems Specialist is a hands-on, highly visible position responsible for assisting the Associate Quality Systems Manager in administering and managing the electronic quality system, utilized by MacroGenics across all parts of the company. The incumbent in this role will assist in all aspects of administration such as managing user accounts, workflows, custom field and data structure management, and data input.

Responsibilities and Job Duties

* Acts as support administrator within MasterControl in order to assist Associate Quality Systems Manager with administration of the MasterControl quality management system.
* Contributes to and maintains vendor system standards.
* Serves as the main point of contact for user administration within MasterControl incluing creating, changing, and disabling user accounts per approved procedures.
* Coordinates MasterControl end user training along with new employee training.
* Responds to internal help desk ticket requests and provides solutions to end users.
* Works with the vendor to troublshoot and resolve application issues.
* Provides guidance to the GMP group in completing/processing audits and quality event records in MasterControl (eg Deviation, Change Control, CAPA, etc).
* Performs other duties as assigned.

Qualifications

Education & Experience

* High School Diploma with minimum of 3 years of related experience in the biotech/pharmaceutical industry; or
* Bachelor's degree in a scientific discipline with minimum of 1 year of related experience in the biotech/pharmaceutical industry.
* Prior Industry experience with FDA 21CFR Part 11 validated systems.
* Hands-on experience as a previous super-user/support administrator for an electronic quality system such as MasterControl. This includes an electronic document control, training, and quality event software package.
* Hands-on experience with reaching out to software vendor to address technical issues.
* Hands-on experience with providing end user support and training for a quality management system such as MasterControl.
* Experience working with software vendor for entering technical issues and seeing them progress to a resolution.

Knowledge, Skills and Abilities

* Understanding of 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems
* Knowledge of FDA GCP, GLP, and cGMP requirements
* Strong time management skills
* Demonstrated ability to and train others
* Must have the ability and desire to work cross-functionally with diverse employees and external users in a cooperative and friendly manner.
* Must possess ability to handle multiple priorities in a fast-paced environment.
* Must possess excellent written and verbal communications skills.
* Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

Supervisory Responsibilities

None

Preferred Qualifications

Prior Experience with MasterControl

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.