Compliance Systems Analyst at 2291 Roche Molecular Systems in Branchburg, New Jersey

Job Description:

Branchburg is the molecular diagnostics manufacturing engine within Global Operations and a Polymerase Chain Reaction (PCR) center of excellence.  As the largest DIA manufacturing site in North America, our teams deliver a broad portfolio of PCR-based in-vitro diagnostic tests. Our operations include reagent and active diagnostic ingredient (ADI) production, filling and packaging. Our 63-acre site with ~1400 people is currently under expansion, fueled by our culture of agility, innovation and transformation. Each day we focus on delivering the value of Roche Diagnostics to patients around the world.

As part of the Operations Information Management team, the Compliance Systems Analyst provides technical assistance through skill sets including, but not limited to, proficiencies with Java, Visual Basic, and advanced formulas in spreadsheet applications, in identifying, evaluating, and developing computerized systems and procedures that are cost-effective and meet user requirements. This includes configuring system settings and options; planning and executing unit integration and acceptance testing; creating specifications for systems to meet business requirements, determining system specifications and working parameters for hardware/software compatibility, designing and developing details of automated systems including provision of consultation to users in the area of automated systems as well as potentially leading cross-functional linked teams to address business or systems issues.

Responsibilities

• Assists the business in the use and utilization of Quality Information Systems; ERP/SAP, LIMS, eDocCompliance, TrackWise, SDR-WinDream, Crystal Enterprise or other Compliant Systems used with the RMS Quality System, participates and contributes in small project requests and large (portfolio) projects, performs support for the productive applications and ensures compliance to corporate and global Roche and Diagnostics standards.




• Consults business in use and utilization of IT Systems Applies business process functional knowledge to manage the design and improvement of those processes with the objective to improve systems utilization while maintaining compliance with the CFR Part 820, 21 CFR Part 11 as well as ISO-13485 and other GxP related authorities, while improving business efficiencies. Presents new or upgraded system capabilities and drives knowledge to users. Creates and deploys training materials for Roche Quality systems.




• Participates and contributes in portfolio projects according to roles and responsibilities orientation of the project.




• Performs support of production applications by responding to service desk calls, tracking problems/issues, and following up with customers. Investigates business and/or applications problems. Determines root cause(s), develops and evaluates alternative solutions, and coordinates selection and implementation of solution.




• Assists in projects related to Computer Systems Validation. Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Reports. Performs system testing and validation.




• Ensures compliance with corporate and global Roche and Diagnostics standards (e.g., Roche and Diagnostics Core, IT Project Methodology, CSV rules & guidelines).

Requirements

• Bachelor's degree in Computer Science, Information Technology or related field required.




• 1 to 3 years of direct related experience.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company’s health and safety obligations and/or applicable law or guidelines.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

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