Day to day:

Our client is looking for a Sr. Specialist Quality Assurance IT to join their team in Durham, NC! This individual will be brought on to help support the Quality Operations team on a new and exciting expansion project at the site.

Key Responsibilities

Providing the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations)

Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e. g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans)

Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective

Supporting regulatory inspection and audit activities which includes the review of audit or inspection reports, replying to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance

Driving resolution of regulatory non-conformance for GMP computerized systems

Monitoring and conveying system health, compliance and other metrics updates to key stakeholders

Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices

Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues

Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems

Mentoring, training and developing QA IT Specialist

Preferred

Professional Certifications (e. g. Six Sigma or certification in Project Management (PMP)

Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations

Project management skills combined with a since of urgency and a proven history producing quality deliverables

Ability to respond to changing priorities
Required

Bachelor degree , Preferably in Science, Information Technology, Engineering or equivalent

Direct experience and comprehension of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations

5+ years in a regulated pharmaceutical or medical device manufacturing industry

Strong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations

Extensive knowledge of the principles, theories and concepts of computerized system validation/compliance

2+ years of experience delivering validated IT solutions or an application support role in a regulated environment

Principled verbal and written communications including persuading others and developing cross functional relationships both at site and across sites