Oxford Immunotec, Inc.

Sr. Quality Assurance Specialist

US-MA-Marlborough
1 month ago
ID
2017-1816
# of Openings
1
Department
QA/QC

Overview

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.

Responsibilities

  • 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.

Qualifications

  • 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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed