Quality Assurance Specialist

3 days ago

White Plains, United States Master Compliance Full time

Job Opportunity: Consultant – QA IT Quality Specialist

Employment Type: Contract

Location: White Plains, NY (Onsite)

Duration: 6 months with potential extensions


Position Overview:

We are seeking a Consultant – QA IT Quality Specialist to provide expert guidance in IT Quality and Data Integrity programs. The role involves ensuring compliance with GxP regulations and verifying the proper operation of GxP computerized systems post-validation. This position requires collaboration with various teams to establish and maintain compliant policies and procedures, as well as interaction across all organizational levels to fulfill Quality Assurance responsibilities efficiently.


Key Responsibilities:

  • Partner with Corporate IT and IOPS IT teams to ensure IT processes align with the Client's Quality System requirements.
  • Apply Quality Risk Management (QRM) principles to both formal and informal risk assessments.
  • Provide expertise in quality system records, including change controls, CAPAs, risk assessments, data integrity, deviations, audits, SOPs, work instructions, and policies.
  • Support IT vendor audits and Quality Assurance Agreement (QAA) development, including the Approved Supplier List (ASL) process.
  • Collaborate with cross-functional teams to gather information and guide quality management initiatives.
  • Ensure new systems, processes, and procedures comply with regulatory requirements and validation guidelines for IT and software.
  • Assist in resolving software application and data integrity concerns during inspection management.


Required Experience and Qualifications:

  • Minimum of 10+ years in IT, Computer Science, Engineering, or Chemistry within an FDA-regulated manufacturing environment.
  • Comprehensive experience of IT CSV (Computer System Validation) and QA IT responsibilities supporting GxP compliance.
  • Experience applying a risk-based approach to validation/qualification in FDA-regulated environments.
  • Strong understanding of FDA CFRs, Eudralex, and other industry regulations related to IT, laboratory systems, automation, and manufacturing.
  • Expertise in Data Integrity, SDLC validation methodology, and software quality requirements.
  • Proficient in root cause analysis and risk management techniques.
  • Hands-on experience with quality management systems such as change control, incident management, and deviation handling.
  • Demonstrated project management skills, with experience leading cross-functional validation efforts (e.g., laboratory equipment, facilities, utilities, manufacturing equipment, and information systems) is a Must
  • Strong technical writing, analytical, and communication skills.
  • Proven ability to drive process improvements and deliver enhanced performance.



If you are an experienced professional passionate about IT Quality and eager to make a meaningful impact in a dynamic environment, we encourage you to apply.

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