Quality Compliance Specialist

Orion Innovation • New Brunswick, NJ

4h

About The Position

Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.

Requirements

• quality assurance mindset for computer system validation
• regulatory expertise to read and interpret global GXP regulations, as well data integrity expectations
• expertise performing test scripts, trace metrics, RRA and other validation deliverables, review and approval as a QA
• 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
• Understanding of Good Documentation Practices
• Project management practices and techniques
• Computer hardware, software including MS Office and MS Project
• 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.

Nice To Haves

• prior experience of REMS, Veeva systems
• 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)
• Experience with automated testing practices and tools preferred
• External and internal inspections support a plus

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 BMS 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level