Vacancy expired!
Sunrise System Inc. is currently looking for
IT Quality Compliance Specialist in New Brunswick, NJ with one of our top clients. Job Title: IT Quality Compliance SpecialistJob Id: 22-08510Location: New Brunswick, NJ 08903Duration: 6 monthsPosition Type: Hourly contract Position (W2 only)Note: Company policy requires newly hired employees to be fully vaccinated for COVID-19 as of their start date. Company gives an equal opportunity employer and will provide reasonable accommodation to the unvaccinated in accordance with federal, state, and local law.Job Description: IT Quality Compliance Specialist/AnalystResponsibilities:- Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and Client requirements.
- Carries out functions of the GxP-ITQA as directed including but not limited to:
- Review and approval of key computer system Validation Life Cycle (VLC) deliverables.
- Review and approval of test scripts and defects associated with computer system validation.
- Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.
- Ensure adequate and timely regulatory compliance support.
- Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
- Provide backup support for the department as needed and perform other assignments as required.
- Support internal and external (regulatory) inspection activities related to validated systems.
- Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
- Experience in the BioTech/Pharmaceutical industry or similar regulated industry required.
- Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
- Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements.
- FDA 21 CFR 11, EU GMP Annex 11, and GAMP 5 standards.
- Data Integrity Guidance.
- In-depth understanding of industry-accepted software development and validation life cycle programs and related IT controls.
- Experience with relevant GxP systems such as quality management systems, document management systems, ERP, training/learning management systems, clinical and laboratory systems preferred.
- Understanding of quality risk-management concepts (ICH Q9) preferred.
- Understanding of ITIL Framework concepts (e.g., Incident, Problem, Change management processes)
- Understanding of Good Documentation Practices
- Project management practices and techniques.
- Experience with automated testing practices and tools preferred.
- Computer hardware, software including MS Office and MS Project.
- External and internal inspections support a plus.
- Excellent analytical, interpersonal, and communication skills, including written and verbal communication.
- Bachelor’s degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.
Vacancy expired!