The Quality Assurance Documentation Control Specialist manages the Electronic Documentation Management System (EDMS). This position will implement best practices and maintain day-to-day operations related to the management of controlled documents. The QA Documentation Control Specialist will develop and maintain knowledge of established work methods, techniques and FDA regulations relating to a cGMP environment.
WHAT YOU WILL DO FOR NOVEOME
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note, as a company rooted in innovation, our positions are consistently evolving, and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.
ATTRIBUTES OF SUCCESS
WORK ENVIRONMENT/PHYSICAL DEMANDS
Subject to extended periods of sitting and/or standing, vision to monitor and typing. Work is generally performed in a temperature-controlled office environment.
This is a non-exempt full-time position with a regular schedule of Monday through Friday work hours. Extended hours may be needed on occasion to complete company objectives.
WHAT NOVEOME WILL DO FOR YOU
Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks. Best of all you will enjoy working with colleagues at all levels in our open receptive work environment.
REPORTS TO QUALITY DIRECTOR
MANAGES OTHERS NO
EDUCATION ASSOCIATE’S or BACHELOR’S DEGREE or EQUIVALENT EXPERIENCE
RELATED DEGREE PROGRAMS ADMINISTRATIVE, BUSINESS, GENERAL STUDIES
WORK EXPERIENCE REQUIRED 3+ YEARS’ EXP. (Associate’s degree) or 1-3 years’ experience with Bachelor’s degree in BIOPHARMACEUTICAL DOCUMENT MGMT OR EQUIVALENT EXPERIENCE
A combination of experience and/or education will be taken into consideration.
ABOUT NOVEOME BIOTHERAPEUTICS, INC.
Noveome Biotherapeutics, Inc. is a dynamic biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug development. Unlike most drugs that are single molecules directed at specific indications, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.
Noveome is an Equal Opportunity Employer.