Laboratory Systems Administrator AR&D
Philadelphia, PA 19019
The Laboratory Systems Administrator is responsible for the oversight and administration of all laboratory computerized systems (standalone and enterprise) in a controlled pharmaceutical laboratory environment. This includes managing the full lifecycle of all components. Additionally, the Laboratory Systems Administrator is responsible for supporting all aspects of the day to day operation of the laboratory computerized systems.
- Lead and manage projects involving procurement, integration and implementation of new and upgrades of laboratory software, instruments, applications and information
- Drive compliance, quality and safety in planning, implementing and maintaining of all new and existing validated/applicable computerized equipment, instruments and information systems.
- Create, revise, review, approve and/or provide input and guidance to Computer System Validation (CSV) documentation, validation related documents, change control documentation and Good Manufacturing Practices (GMP) documentation such as Standard Operating Procedures (SOPs) (where applicable).
- Promptly report deviations, and recommend and execute preventive and corrective actions to continuously improve the quality of laboratory
- Create, coordinate, implement, and maintain data integrity policies in the laboratory to comply with regulatory guidance’s and
- Serves as the point of contact for troubleshooting/issue resolution of laboratory computerized
- Develop and maintain knowledge and understanding of laboratory systems, equipment, instrumentation, and
- Responsible for timely backup of instrument electronic data for all laboratory computerized
- Communicate and collaborate with laboratory management, business stakeholders, Information Technology (IT) department, technical resources, vendors and Contractors
- Multi-task by working on several simultaneous
- Participate in internal and external audits (when applicable), including Food and Drug Administration (FDA)
- Experience working in pharmaceutical industry and/or analytical laboratory
- Demonstrated experience with computer system validation and system lifecycle methodology is a must
- Independent experience and knowledge of the Empower Chromatography Data System.
- Independent experience and knowledge of the NuGenesis Lab Management System, NuGenesis Stability, and NuGenesis Electronic Laboratory Notebook is preferable.
- Knowledge of GMP, Industry Guidelines (ICH/FDA)
- Sound knowledge of 21CFR Part 11 compliance
- Highly organized individual with attention-to-detail
- Comply with all cGMP requirements and Company policies, procedures, rules and regulations
- Must possess excellent verbal and written communication skills
- Strong analytical and problem solving skills
- Demonstrates ability to prioritize conflicting demands
- Performs duties with minimum supervision
- Executes assigned tasks within established schedule
- Knowledgeable with MS Office applications (Word, Excel, Access, Outlook Excel)
- Maintains confidentiality