What are the responsibilities and job description for the qPCR Specialist position at Texcell-North America?
Texcell-North America, located in Frederick, MD, is seeking a full time qPCR Specialist for the Viral Clearance Department. Texcell-North America is a Contract Research Organization providing GLP Viral Clearance and Custom Cell Culture to the biopharmaceutical industry. www.texcell.com
Job Summary
- Works in a BSL2 laboratory according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and Standard Operating Procedures (SOPs), under the supervision of Scientific Director
- Writes technical SOPs
- Designs, troubleshoots, validates, executes qPCR and RT-qPCR assays according to GxP regulations
- Aids in drafting and reviewing protocols, reports, workbooks, and other documentation ensuring conformance to GxP standards and company SOPs
- Completes assigned tasks and meets milestones and timelines
- Trains other personnel as applicable
- Manages and implements appropriate qPCR technical reagents
- Independently executes interpretation and technical analysis of studies
- Communicates with senior management regarding needs (consumables, test materials, personnel, etc.)
- Assists with general organization and management of department and study documents
- Contributes to the overall operations and to the achievement of departmental goals
- Demonstrates thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
- Other duties as assigned.
Minimum requirements
- 2 years relevant experience with qPCR; RT-qPCR
- Experience with qPCR assay design and validation
- Excellent documentation skills
- Effective multi-tasking abilities in a dynamic environment
- Experience independently driving and managing projects
- Ability to troubleshoot and address technical challenges
- Project management experience
- Proficient in Microsoft Office programs, especially Excel
- Excellent time management skills
- Excellent communication skills
- Ability to work in a BSL2 laboratory wearing appropriate PPE
Disclaimer
The above statements are intended to describe the general nature and level of work to be performed. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.