Clinical Laboratory Scientist
Proclinical is currently recruiting for a Clinical Laboratory Scientist with a pharmaceutical company located in Rochester, NY. The Laboratory Scientist supports the Clinical Trials laboratory from testing to validation to quality and associated documentation.
- Assists in instrument and method validations to support clinical trials for Hematology, Chemistry, Special Chemistry, and Flow Cytometry
- Setup and maintenance of laboratory equipment in line with standard operating procedures (SOPs).
- Performs appropriate quality control for reagents, equipment and assays, as assigned.
- Analyzes validation and proficiency testing samples according to validation plans, timeline and standard operating procedures
- Recognizes and documents any deviations from results, escalates issues to management as needed
- Develops and writes standard operating procedures for instruments and methods as required
- Review and quality checks validation documents for accuracy as required
- Document and complete any quality documentation (Quality Issue, CAPA, deviation, change control) as appropriate within the required timeframes.
- Participation in all activities that seek to ensure compliance with GCP guidelines and accreditation schemes (e.g. CAP, ISO, NYSDOH).
Skills and Requirements:
- Bachelor's degree required; life sciences concentration preferred.
- 2+ years of laboratory experience in a clinical research environment preferred.
- Experience with Good Clinical Practices (GCP), CLIA, College of American Pathology (CAP), and/or New York State preferred.
- Strong organizational skills essential with the ability to multi-task and work efficiently.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-291-4181.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.