POSITION SUMMARY: Under limited supervision and with a solid understanding of science and technology, monitors operations and develops and manages quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.
Support the organization in monitoring the compliance of laboratory testing, manufacturing, and clinical research, and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.
Serve as a backup to the Quality site head as necessary which can include attending site meetings to represent Quality, providing guidance to operations in matters of regulatory compliance, and keeping site and departmental leadership informed of critical events.
Represent the Quality unit on cross-functional project teams.
Prepare, maintain, analyze, and present metrics related to the quality or analytical systems.
Manage and maintain programs within the Quality Management System as assigned by the Quality site head, which could include but are not limited to audit, change control, and/or supplier quality programs.
Lead and/or support internal audits, client audits, supplier audits, and regulatory audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up.
Assist in integration efforts and ensure a consistent approach across all company sites wherever possible.
Participate in the general Quality Department oversight activities associated with non-conformances, complaints, lot release, change management, document control, training, equipment management, and other duties as assigned.
Communicate effectively with internal personnel, as well as external customers and suppliers.
Collaborate effectively and positively within department and all other company departments.
Represent department and the organization favorably and in accordance with established Company standards.
Follow all company safety policies & other safety precautions within the work area.
Bachelor's degree in a life science or technical discipline (e.g. biotechnology, engineering) with a minimum of 5 years of related experience, or equivalent combined education and experience.
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
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.
Internal Number: 2018-1876
About Oxford Immunotec
At Oxford Immunotec, we believe the key to building an exceptional company begins with exceptional people. And as a high-growth, post-IPO healthcare company, we’re proud to see that belief transformed into action every day.
Across the globe, Oxford Immunotec is driven by the expectation of excellence. Our proprietary immunology platform is already generating a major impact on human life by creating more effective ways to test for diseases like TB and transforming the diagnostics marketplace in the process. At the same time, we are setting a new standard for careers with our commitment to giving passionate and creative people the freedom to realize their full potential.
At Oxford Immunotec, you’ll find great science driven by intellect, curiosity, and the humility to learn from your setbacks. Every day, we create personal opportunity driven by innovation and extraordinary growth. And, at the heart of it all, you’ll find great people united by the joy of doing important work…and being valued for it. Help drive our future success and join the team at Oxford Immunotec.