Quality Assurance Validation – Medical Device

Job Title: Quality Assurance Validation – Pharmaceutical

Location: Rensselaer, NY (Onsite)

Duration: 6 months extensions

Type: W2/1099/C2C contract

Job Summary:

We are seeking a Quality Assurance IT (QAIT) Consultant to provide expertise in supporting IT Quality and Data Integrity programs within a pharmaceutical organization. The Consultant will serve as a Subject Matter Expert (SME) to guide investigations, risk assessments, and IT operations, ensuring that GxP computerized systems are validated and meet compliance standards. This role requires cross-functional collaboration to establish and maintain policies and procedures in alignment with GxP industry regulations.

Key Responsibilities:

• Support Quality Risk Management (QRM) principles in formal and informal risk assessments.
• Provide guidance on quality system records such as change controls, CAPAs, risk assessments, deviations, audits, SOPs, and policies.
• Assisted in the quality auditing function, particularly regarding IT vendors and audits.
• Contribute to the development, review, and approval of Quality Assurance Agreements (QAA) and the Approved Supplier List (ASL) process.
• Work with cross-functional teams to collect information and provide guidance on quality management systems and improvement projects.
• Ensure compliance of new systems and processes with SOPs, Work Instructions (WIs), and regulatory guidelines for IT and Software validation.
• Support resolving inspection management concerns related to software applications, procedures, and data integrity.

Required Experience:

• 7 years in IT, Computer Science, Engineering, or Chemistry in an FDA-regulated manufacturing environment.
• In-depth knowledge of IT CSV and QAIT roles in supporting GxP compliance.
• Strong experience with FDA regulations, including CFRs, Eudralex, and biotech/pharma industry standards.
• Expertise in Data Integrity, System Development Life Cycle (SDLC) validation, and Software Quality requirements.
• Proficient in root cause analysis and risk management techniques.
• Experience with quality management systems, including change control, incident management, and deviation management.
• Proven Project Management experience leading cross-functional teams in systems validation (e.g., lab equipment, manufacturing systems, IT systems).
• Strong technical writing and communication skills.
• Excellent analytical and problem-solving abilities.