Under limited supervision and with a solid understanding of technology and computer system validation in a regulated environment, is responsible for global administration of the eQMS (EtQ Reliance) software for the company. Serves as global Subject Matter Expert performing administrative functions, project management, validation and change control for the eQMS.
Maintains and enhances effectiveness of the Quality Management System by monitoring and managing the eQMS (EtQ Reliance) software currently used to track document control and training compliance.
Develops and implements quality improvement initiatives utilizing eQMS modules to ensure that the system is utilized to its full capabilities and is maintained in compliance with regulatory requirements.
Manages project teams to ensure proper design, validation, training, and communication occur during implementation of new modules and changes to existing.
Accountable for the compliance of system by partnering with IT and the software vendor to ensure system security, backup, maintenance and upgrades as required.
Writes, edits, and reviews procedures, work instructions, and validation documents associated with the eQMS.
Collaborates to develops and provide training and technical assistance for the eQMS to new hires and ad hoc as needed.
Develops and reports metrics reports from the eQMS to management for actions needed to ensure compliance.
Maintains data integrity and ensures compliance with company SOP’s, specifications; as well as CAP/CLIA, HIPAA, cGXP, ICH, FDA, and other local, state and federal regulations or guidelines.
Ensures proper paper and electronic record retention related to the eQMS.
Bachelor's or Associate’s Degree in technical discipline (e.g. IT, biology, biotechnology, engineering) or related life science with minimum of 2-5 years’ of related experience
Strong knowledge in Computer System Design and Life Cycle required
Excellent project management skills are a must.
Strong attention to detail and Quality commitment
Strong written and oral communication with all levels
Experienced in working to CAP/CLIA/GXP and Quality Management principles
Conscientious, thrives in high pressure work, and demonstrates strong initiative
IT infrastructure and coding and/or EtQ Reliance experience is a plus
PHYSICAL DEMANDS: The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions. The Company's first product is the T-SPOT®.TB test, which is used to test for tuberculosis infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where... it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company's second product line is a range of assays for tick-borne diseases, such as Lyme disease, obtained through the acquisitions of Imugen and Immunetics. Also obtained through the acquisitions is the Company's third product line focused on screening for Babesia in donated blood, for which the Company is currently seeking FDA licensure. The T-SPOT.CMV test and the T-SPOT.PRT test are pipeline products as part of the Company's fourth intended product line focused on the transplantation market. In addition to these four product lines, the Company has additional active development programs in other immune-regulated conditions. The Company is headquartered near Oxford, U.K. and in Marlborough, Mass. Additional information can be found at www.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd. Immunetics is a trademark of Immunetics, Inc.
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