Sample Data Management Specialist
3 days ago
Eurofins USA PSS Insourcing Solutions is seeking a highly skilled Sample Data Management Specialist to support our efforts in acquisition, qualification, testing, and implementation of sample materials. The ideal candidate will possess strong scientific and organizational skills, proficiency in MS Project and MS Visio, and excellent communication skills.
Key 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 BVA.
- Perform appropriate second scientist and second person review as required.
- Build and maintain Research LIMS specifications and specification lists for vaccine and biologics franchises.
- Serve as primary trainer and subject matter expert for BioInventory systems.
- 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 in OpenLab, DeltaV, or BAS PI.
- Strong scientific and organizational skills.
- Proficiency in MS Project and MS Visio.
- Excellent communication (oral and written) skills with both English and ESL speakers.
- 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.
- Experience in statistical analysis using with JMP, Minitab, or Excel.
- Technical writing experience.
- Experience with regulatory audits.
Basic Minimum Qualifications:
- Bachelor's degree in biology, chemistry, or other related degree concentration with 2-3 years of related experience, or Master's degree with 0-1 year experience.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
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