Analytical Systems Specialist

Samsung Biologics•Rockville, MD

7d•$83,325 - $111,100•Onsite

About The Position

Samsung Biologics is seeking an Analytical Systems Specialist to join their biopharmaceutical manufacturing site in Rockville. This role is crucial for performing administration duties for analytical systems within Quality Control, Manufacturing, and MS&T Analytical departments. The specialist will be responsible for fulfilling, maintaining, and auditing access requests from system users, and drafting documents related to the installation and compliance of analytical systems. Key functions include interfacing with Validation, IT, and vendors for the implementation of new systems and technology, managing the system lifecycle, and providing technical troubleshooting. The role also involves serving as a system administrator, supporting new analytical system start-up and validation, and ensuring analytical systems operate in compliance with validation requirements. Additionally, the specialist will provide instrument support, assist with laboratory equipment lifecycle management, and author/revise SOPs and technical documents.

Requirements

BS/BA degree in a scientific field, or equivalent with relevant experience.
3-5 years GxP experience.
Working knowledge of various analytical systems.
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.
Fully versed in GMPs, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.

Responsibilities

Perform administration duties for analytical systems within Quality Control, Manufacturing and MS&T Analytical departments.
Fulfill, maintain, and audit access requests from system users.
Draft documents related to installation and compliance of analytical systems.
Interface with Validation, IT and vendors for implementation of new systems/technology.
Manage the lifecycle of analytical systems.
Provide technical troubleshooting for analytical systems.
Support new analytical system start-up and validation.
Support user access provisioning and auditing as necessary.
Support analytical system data integrity assessment/gap mitigation.
Ensure analytical systems operate in compliance with validation requirements.
Provide instrument support as needed to system owners.
Support efforts throughout the lifecycle of laboratory equipment, from planning through decommissioning.
Author, revise, and review SOPs and technical documents as necessary.
Ensure analytical system-compliant procedures are in place and in use.
Participate in audits/inspections.