Laboratory Sample Data Management

Eurofins USA PSS Insourcing Solutions•West Point, PA

6d•Onsite

About The Position

Support efforts in acquisition, qualification, testing, and implementation of sample materials through the physical sampling, labeling, distribution (import and export), and monitoring of these samples globally. Serve as primary logistics coordinator for major vaccine and biologics franchises in Analytical Research & Development. Perform appropriate second scientist and second person review as required. Build and maintain Research LIMS specifications and specification lists for vaccine and biologics franchises. As required, train on laboratory methods supporting key analytical method transfer activities. Ensure all work is compliant with all regulatory expectations. Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the position. Perform aliquot of biological critical reagents and document in ELN. Perform Quarterly Equipment and logbook review. Perform Review of Equipment Temperature Data.

Requirements

Bachelor's degree in biology, chemistry, or other related degree concentration with 2-3 years of related experience
Authorization to work in the United States indefinitely without restriction or sponsorship
Strong scientific and organizational skills
Excellent communication (oral and written)
High level of attention to detail, in particular with the preparation of GMP documentation and the work associated with that documentation.
Ability to work independently and on a team
Highly self-motivated, expected to contribute to the work and take ownership of projects
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Experience in classical biochemical assays and molecular biological techniques
GMP experience
Technical writing experience
Experience with regulatory audits

Responsibilities

Support efforts in acquisition, qualification, testing, and implementation of sample materials through the physical sampling, labeling, distribution (import and export), and monitoring of these samples globally.
Serve as primary logistics coordinator for major vaccine and biologics franchises in Analytical Research & Development
Perform appropriate second scientist and second person review as required
Build and maintain Research LIMS specifications and specification lists for vaccine and biologics franchises
Train on laboratory methods supporting key analytical method transfer activities.
Ensure all work is compliant with all regulatory expectations
Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the position.
Perform aliquot of biological critical reagents and document in ELN
Perform Quarterly Equipment and logbook review
Perform Review of Equipment Temperature Data