Analytical Systems Specialist
$83,325–$111,100 year
On-site · Rockville, Maryland, United States
Job Summary
Analytical Systems Specialist responsible for administering analytical systems across Quality Control, Manufacturing, and MS&T Analytical, managing user access provisioning and auditing, drafting installation/compliance documents, interfacing with Validation, IT and vendors for system implementations, overseeing lifecycle management and technical troubleshooting, supporting system start-up/validation, ensuring data integrity and regulatory compliance, authoring and reviewing SOPs and technical documents, and collaborating with cross-functional teams to support instrument and equipment lifecycle from planning to decommissioning.
Required Qualifications
- BS/BA in scientific field or equivalent experience
- 3-5 years of GxP experience
- Working knowledge of various analytical systems
- Experience with GMPs, NIH, ICH Guidelines, FDA, and other regulatory requirements for validation and operations of analytical and stability functions
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