"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". Job Title: Validation - IT Quality Compliance Specialist/Analyst
Location: New Brunswick, NJ (Hybrid)
Duration: 6 months
Pay rate: $60 to $68 W2 Deal
Job Description: 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.
Responsibilities:- 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 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;
- External and internal inspections support a plus;
- Excellent analytical, interpersonal, and communication skills, including written and verbal communication.
Education:- Bachelors degree required in a related field from an accredited college or university, with a minimum of 8 years of related experience.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.