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Software Quality & Compliance Investigator

8+ years
Not Disclosed
15 June 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

Position - Software Quality & Compliance Investigator - Validation NC/CAPA

Location - Raritan, NJ

Duration - Full Time with Quantum

 

Job Description:

  • Leading, coordinating, conducting and documenting GxP process nonconformances that are caused by Computer System Failures/Issues

  • Fostering collaboration and teamwork across multiple functional teams and stakeholders

  • Working knowledge and understanding of SDLC principles, processes and tools

  • Utilizing formal Root Cause Methodologies to determine root cause

  • Authoring Quality Investigation Reports that clearly and succinctly describe the nonconformance/issue, explain its root cause, and document the corrective action plans designed to mitigate existing risks and prevent reoccurrence.

  • Analyzing evidences and artifacts that support investigation facts, conclusions and corrective action plans

  • Explaining/Defending Quality Investigation Reports and responding to internal/external auditor scrutiny

  • Reviewing & Communicating Quality Investigation trends and KPIs

 

Qualifications:

Requires Excellent:

  • Verbal Communication Skills to obtain and share investigation details with business, technical and compliance SMEs

  • Excellent Compliance Writing Skills to author GxP documents & artifacts that are scrutinized by internal and external auditors

  • Ability to ‘Connect the Dots’ to ensure investigation details and artifacts represent an accurate and complete summary of the nonconformance that can be confidently defended in audits

  • Investigational Skills to be able to ask good, pertinent questions in order to gather all necessary facts from cross-functional teams

  • Critical Thinking Skills to be able to challenge inaccurate or incomplete facts

  • Organizational Skills to manage large amounts of data, information and artifacts that are submitted from various functions and stakeholders

  • Project Management Skills to ensure critical Investigation milestones and timelines are met

  • People Skills to be able to work with cross-functional colleagues and stakeholders having various levels of understanding

  • Attention to Detail

  • Respect for Timelines and Sense of Urgency

  • Ability to escalate when necessary