Senior Histology Analyst

Position Title: Senior Histology Analyst

Work Location: Branchburg, NJ 08876

Assignment Duration: 6 months (possible extension- performance based)

Position Summary: The role involves lab work, analytical activities, equipment validation, Data Integrity Risk Assessments, process improvements, and related quality activities supporting a histology laboratory environment. Work combines hands-on laboratory activities with analytical and quality-related responsibilities.

Background & Context: Candidates will initially receive extensive training to become familiar with how the lab operates and to observe technical work. The team is currently focused on equipment validation work involving a cryostat and two flash-freeze units, with additional freezers coming in.

Key Responsibilities:

* Execute technical work including tissue processing, grossing, embedding, sectioning, staining, and analysis.

* Perform equipment validation work involving a cryostat, flash-freeze units, and freezers including writing and executing protocols. * Focus on the frozen technical sample preparation area where equipment validation is needed, introducing paraffin work later or dividing among team members.

* Drive histology automation and process improvement activities.

Conduct document updates and change controls from a quality perspective.

* Perform Data Integrity Risk Assessments and System Classifications from the QA perspective.

* Utilize LIMS for operation, integration, or development activities.

* Lead investigations and Root Cause Analysis for senior-level quality responsibilities.

Qualification & Experience:

* GMP/GXPs experience is required for all positions.

* Bachelor's degree in Biology minimum; candidates certified in histology preferred.

* Experience or training in the lab with hands-on technical skills. * Equipment validation and qualification experience within a GMP environment. * Experience with microscope slide analysis and/or digital imaging and analysis.

* Leadership skills. * Experience with document updates, change controls, and LIMS (development, integration, or operation).

* Experience performing Data Integrity Risk Assessments and System Classifications. * Understanding of the investigation process and Root Cause Analysis background for senior-level candidates.

* Flexibility on histology years of experience (3-7+ years) when accompanied by strong equipment validation, QA, LIMS, or Data Integrity skills.

* Candidates with PhD or MD considered if possessing required hands-on technical skills. * Must be able to be onsite within approximately two weeks if relocating.