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Sunrise System Inc. is currently looking for IT Quality Compliance Specialist/Analyst in New Brunswick, NJ with one of our top client.
Job Title: IT Quality Compliance Specialist/Analyst
Job Id: (phone number removed)
Location: New Brunswick, NJ 08903
Duration: 6 months
Position Type: Hourly Basis on W2 only
Note:
Hybrid role–50% onsite presence is required
Work Schedule: Mon – Fri, Business hours
There are TWO openings for this role
Responsibilities:
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.
Qualifications:
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.
Education:
Master of Science with 3 years’ experience or a Bachelor of Science with 5 years’ experience or Diploma holders with commensurate experience in regulated industry (e.g. 10+ years)
University graduate (science degree preferred)
Top Must Have’s to be Successful in this role:
Master of Science with 3 years’ experience or a Bachelor of Science with 5 years’ experience or Diploma holders with commensurate experience in regulated industry (e.g. 10+ years)
University graduate (scie
