Alphanumeric is hiring an Analytical Support Specialist to work in Rockville, MD with one of the largest pharmaceutical companies in the world.
- Serve as system administrator on laboratory systems to identify, analyze, and troubleshoot problems.
- Assist with development of system administration process
- Deliver user, process, and technical specifications and design documents.
- Assess laboratory systems for regulatory compliance requirements.
- Implement solutions to ensure laboratory systems compliance
- Develop and report key usage and performance metrics for systems.
- Provide user training and support.
- Manage efforts throughout the lifecycle of laboratory equipment. From planning thru decommissioning.
- Assist with development of laboratory system lifecycle management process
- Author, revise, and review SOPs as necessary.
- BS degree in scientific discipline
Area of Specialization* Laboratory system experience and general GMP
- Preferred Level of Education BS/ MS
Area of Specialization Laboratory system and Computer Science
- 3-5 years of experience managing information systems in a GxP regulated environment
- Strong interpersonal and leadership skills.
- Solid team player able to function within a team-based organization.
- Strong verbal and written communication skills.
- Able to interact with peers and senior personnel in a multidisciplinary environment including validation, production and IT
- Ability to prioritize and decide appropriate course of actions. Effective at implementing decisions and multi-tasking.
- Fully versed in GMP’s, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.