IT Quality Compliance Specialist/Analyst

IT QUALITY COMPLIANCE SPECIALIST/ANALYST NEW BRUNSWICK, NJ Hybrid - Requires Onsite 2-3 days per week. Required Skills:

• Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.
• 21CFR11/ EU GMP Annex 11 and GAMP 5 standards.
• Data Integrity Guidance
• Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Project management practices and techniques.
• Software development life cycle.
• Computer hardware and software applications including Quality related computer systems, MS Office, and MS Project.
• Principles and practices of computer compliance, validation, and qualification.
• Knowledge of automated testing practices and tools a plus.
• External and internal inspections.

• Managing and coordinating activities related to cGMP Enterprise Electronic Systems.
• Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications.
• Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems.
• A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the GPS enterprise.
• The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements.
• This role will also provide support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.
• Responsibilities also include providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
• Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
• Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
• Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation, and the overall maintenance of system state of control.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
• Performs quality reviews of computer systems validation deliverables.
• Reviewing user, functional and design specifications.
• Reviewing and executing protocols and test scripts.
• Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
• Managing multiple projects, duties, and tasks.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining effective working relationships with those contacted in the course of work.