Location
Petaluma, CA, United States
Posted on
Jul 02, 2013
Profile
More information about this job:
Overview:
Responsible for implementing, maintaining, and overseeing the data systems used within the ASD laboratory (for example, laboratory chemicals and test samples inventory, equipment calibration database, Data Acquisition and processing for routine and specialized analytical techniques such as HPLC, UV-Vis, FT-IR, micro-plate readers, LC-MS, etc.) Education/ training, and experience in GXP regulations that address computer applications and pharmaceutical quality assurance principles and knowledge of current FDA expectations. Knowledge of recommended practices and guidelines for computer system validation is a plus. Capable to research, comprehend, self-learn, implement, and maintain new computer software and systems. Able to work with vendors and contractors for acquiring quotes on new systems, organizing on-site trainings and finalizing long-term service agreements, as needed. Excellent interpersonal, written, and verbal communications skills are also necessary. Must be able to work in a complex, fast paced environment, prioritize and multi-task.
Responsibilities:
Maintain network infrastructure such as switches and routers, and diagnoses problems with these or with the behavior of network-attached computers
Apply operating system updates, and configuration changes
Install and configure new hardware
Manage change control documentation for systems
Develop and execute computer systems validations in accordance with the GXPs, regulatory requirements and company procedures
Develop, test and execute Disaster Recovery and database backup plans
Perform Database backups
Programming (scripting, automating tasks)
Performance tuning of Oracle database
Maintain data systems
Evaluate software updates to determine cost effectiveness of application improvements (weigh improvements vs re-validation, re-training)
Manage user accounts on data systems
Manage user accounts on clients (operating system accounts)
Manage configuration of the system
Troubleshoot reported problems
Train users
Assist users (e.g. answer technical queries)
Qualifications:
Bachelor’s degree in Computer Sciences or related scientific field with approximately 3-5 years IT experience in Pharmaceutical/Analytical environment.
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