The IT Quality Systems Analyst establishes and maintains ASP's IT Quality Systems in accordance with the ASP QMS, global regulatory requirements, and industry best practices. As an integral part of the team, the IT Quality Systems Analyst will work with cross-functional stakeholders to select solution vendors and design, validate, implement, and manage changes to and support for ASP's Quality System and related applications and integrations. Candidate should be a strong leader with the ability to work cross-functionally in a global environment.
* Work closely with business to gather business requirements and design and implement Quality Management solutions to effectively address those requirements. * Contribute to the development of the company-wide IT Quality processes and tools, including infrastructure qualification, system validation, change management, backup, and management of hosting and service providers. * Lead assessments of IT systems and system changes for GxP implications and potential risk to quality, compliance, and record integrity. Establish validation plans in accordance with identified impacts and risks. * Lead system validation activities, such as eliciting user requirements with functional stakeholders and managing validation projects, including oversight of vendors and contractors. * Establish validation deliverables, including strategies, plans, risk assessments, requirements and design specifications, migration strategies, test protocols and scripts, trace matrices, support plans, and validation reports. * Perform regression analysis, verification, and validation testing of new and changed systems. * Collaborate with other IT teams to design, develop, and support integration between Quality Management systems and other Enterprise on-premise or cloud applications. * Provide support to end users for the Quality Management applications, including determining root causes of problems as well as fixing issues.
* Minimum 7 years' experience in establishing and maintaining quality systems in FDA regulated environments. * Knowledge of relevant regulations (21CFR820, 21CFR11, EU MDR Annex 11) and guidelines (GAMP, PIC/S, ICH) * Experience with system validation, training, change management, CAPA, Non-Conformance, and supplier audits * Ability to travel globally as needed for incidents and meeting with business/IT staff for projects up to 10%.
* Experience working with SAP ERP, SFDC CRM, Labware and Empower LIMs, and QMS solutions such as EtQ or MasterControl. * Strong verbal and written communication skills. Ability to effectively communicate and translate highly technical information in a professional manner at all levels. * Comfort working in a team, talking to clients, mentoring colleagues, and documenting processes. * Aptitude for learning and capable of working in a fast-paced environment. * Ability to produce high-quality deliverables while working independently or as part of a team. * Enthusiastic, highly motivated, quick learning, creative problem solving, proactive and curious.
Associated topics: equipment, infrastructure, ip, network, satcom, satellite, server, system engineer, system technician, technician
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.