HISTOLOGY - ASSAY DEVELOPMENT SPECIALIST - ANATOMIC PATHOLOGY BERGEN COUNTY, NJ
Shift: Monday-Friday, 9:00am-5:30pm (subject to change based on business needs)
Position Summary:
The Assay Development Specialist I, Anatomic Pathology manages the validations and enhancement of clinical tests and services in the following areas: Histology, ISH, IHC, and Image Analysis at the local site level. The Specialist provides insight to assay design, performs validations, and works cohesively with the local AP department to maintain assays and instrumentation for the department.
This is a technical role that reports to the Assay Development Manager for Anatomic Pathology. This role requires a combined set of strong technical and interpersonal skills. The Assay Development Specialist I must have high understanding of laboratory techniques and clinical lab practices. The Assay Development Specialist I has ongoing opportunities to mentor junior members of the department and interact with numerous levels of staff in other departments.
Core Responsibilities:
- Demonstrate initiative in making suggestions to improve efficiency throughout the AP lab section
- Prepare validation summary for each completed validation
- Assist in maintaining documentation and slides per CAP/CLIA regulations
- Basic knowledge of regulatory regulations
- Assist in troubleshooting of test performance and instrumentation issues
- Performs the bi-annual instrument and/or assay correlations as assigned
- Assist in the IQ/OQ/PQ process for all instrumentation per SOP
- Assist in maintaining and enhancing existing assays as assigned
- Perform staining for assay validation per SOP or established validation plan
- Proficient with department staining and scanning platforms and programs
- Assist in specimen procurement for validation as assigned
- Prepare and update internal document for review
- Assist in coordinating instrument maintenance and service
- Assist with internal PT and AA as assigned
- Proficient in reagent preparation
- Basic knowledge of antibody and IHC staining methods
- Assist in training laboratory staff as assigned
- Provide support to laboratory staff and management to maintain routine operation
Experience, Education and Qualifications:
- Bachelor of Science in chemical, biological, or clinical laboratory science or medical technology (Histotechnology Program) from an accredited institution - OR -
- Associate of Science in a laboratory science, or medical laboratory technology from an accredited institution - OR -
- Equivalent education of 60 semester hours with 24 semester hours in biological and chemical science courses
- 2 years of experience in Histology/Anatomic Pathology required, 4 total years of experience preferred
- HT or HTL (ASCP) required
All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.
Pay Range (will vary based on location & experience) $61,800.00 - $106,605.00 annually, plus bonus
In all instances, the salary paid will satisfy minimum salary laws.