Senior Software QA Engineer (R1108874) in Marietta, GA at IQVIA™

Date Posted: 2/11/2020

Job Snapshot

Job Description

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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Responsibilities

  • Plan, schedule, conduct, report and close compliance activities and processes for periodic review of new and previously validated Q² Solutions applications, as governed by Q² Solutions Operating Procedures on Maintaining The Validated State
  • Serve as, may act as IT Compliance representative to the global QA SOP taskforce
  • Provide guidance, interpretation, support, training, and key input to PM, BA, Dev, Release Management and Production Support groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies as related to SOPS.
  • Serve as primary point of contact for project compliance requirements relating to IT SOPs.
  • Oversee documentation, reporting, and closure of compliance issues.
  • Ensure proper coordination of periodic reviews
  • Participate in or lead (cross functional) teams for special projects as assigned.
  • Work closely with IT Management to support Client, Internal, and Regulatory Audits and Inspections as needed
  • Collaborate with QA Systems Compliance Office to ensure alignment on regulatory requirements

Required Knowledge, Skills and Abilities

  • Regulatory (and associated Standards, Guidelines, and Industry Best Practices) interpretation, implementation, and application of FDA Part 11, GxP and adherence to corporate SOPs.
  • Experience with software validation principles (SDLC and Software Validation Life Cycle)
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Strong knowledge of development and audit processes in regulatory environments.
  • Considerable knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation and leadership skills.
  • Ability to influence and guide others
  • Management experience in Audit and/or Quality Assurance
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Minimum Education and Experience

  • Bachelor’s degree in Computer Science or a related field required; or equivalent combination of education and experience
  • Five (5) years related experience in quality assurance, testing, and Audits
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
  • Travel may be required  

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.



Job ID: R1108874