Join Samsung Biologics' biopharmaceutical manufacturing site in Rockville, as an Analytical Systems Specialist.
Essential functions include performing administration duties for analytical systems within Quality Control, Manufacturing and MS&T Analytical departments in Samsung Biologics, fulfilling, maintaining and auditing access requests from system users, and drafting documents related to installation and compliance of analytical systems. Other functions: interface with Validation, IT and vendors for implementation of new systems/ technology, lifecycle management, and technical troubleshooting.
- Serve as system administrator for analytical systems.
- Support 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.
- 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
- Ensure analytical system-compliant procedures are in place and in use, participate in audit/ inspections.
Minimum Level of Education:- BS/BA degree in scientific field, or equivalent with relevant experience
Minimum Level of Job-Related Experience, Knowledge, & Technical Skills Required - 3-5 years GxP experience with working knowledge of various analytical systems
The anticipated salary range for this position in Maryland is $83,325 to $111,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment
