The Business Applications System Analyst will be primarily responsible for technical role to support Quality Control equipment software and firmware in addition to supporting administration and maintenance of Argos cGMP applications used for Quality Control, Quality Management, Document Management, Manufacturing Execution Systems, Calibration/Maintenance, and Environmental Monitoring.
The ideal candidate will possess a strong work ethic, the desire to work on a collaborative team, and a passion for creative thinking and problem solving:
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors
- Exercises judgement within defined procedures and practices to determine appropriate action
- Builds productive internal/external working relationships
- Plans and directs the analysis of complex business problems to be solved with automated systems.
- Provides technical assistance in identifying, evaluating and developing systems and procedures that are cost-effective and meet user requirements.
- Configures system settings and options; plans and executes unit integration and acceptance testing; and creates specifications for systems to meet business requirements.
- Determines system specifications and working parameters for hardware/software compatibility.
- Provide consultation to users in the area of automated systems.
- Lead cross-functional linked teams to address business or systems issues.
- Responsible for technical role under supervision of the technical lead to support QC equipment software and firmware validations. (e.g. flow cytometers, gel imagers, spectrophotometers, non-viable particulate counters)
- Develop professional experience under supervision of technical leads to provide daily technical support to users in support of cGMP systems. This includes database administration, design, management, and maintenance. cGMP systems include QC equipment, MasterControl, FactoryTalk PharmaSuite, ProCal, and MODA-EM.
- Create, collaborate, and review/approve validation lifecycle documentation including requirements, specifications, and testing documents.
- Evaluate product enhancements and capabilities; create and follow through with cGMP application change controls.
- Liaison between software vendors, IT, and technical support groups.
- Bachelor’s degree in scientific discipline or computer science.
- Knowledge of FDA cGMP and related regulations and guidelines including 21 CFR Part 11.
- Minimum 2 years’ experience with quality control equipment and associated software systems
- Specific knowledge of computer validation methodologies, principles, and software development life-cycles.
- Good communication and interpersonal skills required
- Must have initiative, high attention to detail, and the ability to multi-task.
- Ability and willingness to be regularly, predictably and reliably at work.