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Quality Manager, Software Testing

Aplica ya
Mapa de ubicación: Columbia, Maryland, United States Full time R1249720

Descripción del trabajo

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.

Job Overview

Position Overview manages the quality effort at BioFortis for quality assurance and control review, as well as provides direct support for the continued development, sustainment, update, and maintenance of the Company’s Quality Management System. Interprets complex technical and regulatory requirements in order to develop, write and edit clear, understandable policies and procedures that will ensure that BioFortis integrates quality into its operations. Serves as key evangelist for quality. Essential Job Functions • Develop monitoring and management programs that produce compliance to applicable regulations, corporate directives and the Quality Management System (“QMS”).

● Conduct internal audits and perform other administrative duties as may be required, consistent with the QMS.

● Lead and manage responses to quality audits and inquiries from third parties. Conduct document reviews for quality documents to ensure applicability of current quality policies, procedures and objectives by keeping informed of the latest updates / modifications. Act as a process champion for continuous improvement of BioFortis processes and quality systems.

● Identify applicable responsibility to resolve Corrective and Preventative Action (CAPA) requests and track to resolution.

● Suggest, implement and monitor key process metrics in order to improve processes.

● Monitor and report on compliance to the QMS.

● Interact with all functional areas of BioFortis as Quality “champion” by promoting, teaching and presenting quality as a means for process improvement and efficiency through the management of the Quality Advocates.

● Develop and present quality-related training programs / presentations to all levels of management. Supervision

● Reports to Chief Operating Officer. Works under general supervision but has latitude to prioritize own tasks and manage schedule.

Responsibilities

• Assist with receipt of consignments and shipments.

• Assist with Visit Specific Kit (VSK) receipt, including opening of consignments and shipments.

• Check quality of patient information forms.

• Correctly dispose and/or recycle kit shipping supplies and ensure that specimens are not left in kit packaging.

• Assist with general clean up after kit opening including disposing of kit opening rubbish.

• Conduct secondary check of shipping materials

• Perform various administrative duties as required including checking of consignment notes, shipment tracking, and faxing, filing.

• As required, perform kit receipt and requisition QC checks.

Minimum required education and experience

• Bachelor's Degree in a Science Discipline preferred

• Equivalent combination of education, training and experience

Required knowledge

  • Regulatory (and associated Standards, Guidelines, and Industry Best Practices) interpretation, implementation, and application of FDA Part 11, GLP, GMP, GCP, CLIA, QSR, ERES; Annex 11; ISPE GAMP 5, ISO 9001, 15189, ICH E6,

Required experience

  • Experience with software validation principles (V model) (SDLC and Software Validation Life Cycle)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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