The Quality Manager is responsible for the development, deployment and maintenance of our cGMP/ISO 9001:2015 Quality Management System and Hazardous Communications Program. This Position requires working closely with the President and Vice President to administer and maintain these systems. Experience with chemical analysis and a demonstrated working knowledge of FDA, ISO and international medical device regulations is highly desired. This is a “hands-on” position in the daily operations of the QMS.
Establish and maintain day to day operations of the QMS (ISO 9001:2015, FDA 21 CFR 820, CFR 210, CFR 211) and Safety programs
Apply knowledge in regulations and external standards to guide and coach process owners in the development of compliant processes and procedures.
Monitor cGMP/cGLP studies to assure compliance with regulations and review final reports
Creation, revision control, retrieval, approval routing, and distribution for all standard operating procedures, and company policies in accordance with Document Control requirements
Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s services and products
Responsible for accuracy and timely inspection/calibration of all monitoring and measuring devices
Administer CAPA and deviation investigations, customer complaints, and non-conformances.
Conduct annual management review, internal audits and host customer audits
Maintain day to day operations of the Hazardous Communications Program
Responsible for maintain the integrity of the training system, including the oversight and development of training curriculums and programs
Any other duties as directed
Researching sources for services and products
Any other duties as directed
Minimum education/job experience:(where possible list equivalent experience for educational requirements)
Bachelors degree in Chemistry or Related Scientific Field preferred or related work experience
Demonstrated understanding of the relevant regulations, standards ISO 9001:2015, FDA 21 CFR 820, CFR 210, CFR 211 is required
10+ year’s industry experience with demonstrated knowledge of Quality Management systems is preferred.
2+ years in a leadership role
About Jordi Labs
Jordi Labs aims to provide the highest quality products and services to the polymer, pharmaceutical, nanotechnology, and biotechnology industries. Quality is central to who we are as a company. Jordi Labs’ existence depends on the quality designed into each of our products and specialized analytical testing processes, by every employee instilled with pride, working together and sharing what we learn with one another. We have a certified ISO 9001 quality system that we continuously improve while seeking to improve customer satisfaction.
Jordi Labs specializes in the production of polymer based chromatography media and GPC columns. Our divinylbenzene (DVB) gels provide a longer lasting and more versatile column media. Jordi Labs produces a wide range of polymer based products for reverse phase (RP), normal phase (NP) and ion exchange chromatography. New and innovative GPC (Gel Permeation Chromatography) products remain central to our development efforts.
Jordi provides contract analytical services with a special emphasis on chemical identification. Typical projects include product failure analysis, HPLC method development, polymer filler and additive quantit...ation, and unknown identification. Our team of PhD biological and polymer chemists have extensive expertise in a broad range of today’s most advanced analytical techniques including Mass Spectrometry, Gas and Liquid Chromatography, Elemental Analysis, and Spectroscopy. Our goal is to provide the best customer service in the industry, backed by more than 3 decades of technical expertise.
INTEGRITY, THE “JORDI WAY”
The “Jordi Way” is the manner in which we perform work at Jordi Labs. It is a culture that has been cultivated at Jordi Labs which continues to demand that we provide the best possible service to our customers. It is defined by words like integrity, responsibility, diligence and excellence. It means that we work until the job is finished, never giving up on a resolution. It can also be described as following the Golden Rule of “Do unto others as you would have others do unto you.” We endeavor every day to give our customers the kind of service that we would expect from highly skilled chemists. It’s not enough that we get the job done; it must be done with excellence. This culture of integrity ensures we work diligently and take responsibility for the results that we provide.