"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: IT Quality Compliance Specialist/Analyst

Location: New Brunswick, NJ 08903 (Remote)

Duration: 6 months

Pay rate: $72 - 78.57/ hour on W2

Job Description:

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 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:

• Bachelors degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.

Must haves:

• Ideal candidate would have prior experience of Maximo Enterprise Asset Management system
• quality assurance mindset for computer system validation for GMP, GLP space.
  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

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.