- 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
Qualifications :
Basic Minimum Qualifications :
- Bachelors degree in biology chemistry or other related degree concentration with 23 years of related experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess :
- 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 selfmotivated 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
Additional Information :
Position is fulltime MondayFriday generally 8 a.m. 5 p.m. but may vary to meet the assay needs; overtime as needed. Candidates currently living within a commutable distance of West Point PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime