- Perform assay development, validation and sample analysis according to SOPs and regulatory requirements with minimal supervision
- Interpret experimental results
- Write and maintain study reports, research documentation and laboratory records
- Review scientific data and ensure the quality meets company SOPs and applicable regulatory requirements
- Communicate results to supervisor and sponsors
- Apply knowledge of GLP (FDA, EPA and OECD) and GCP regulations as well as 21
- CFR Part 11 (electronic records and electronic signatures) as applicable to the work of the department
- Cooperate with QA, management, colleagues and clients
- Calibrate/operate/maintain scientific equipment
- Act as a technical resource for basic troubleshooting of assays and instruments
- Interact with sponsors and vendors
- Maintain a clean and safe laboratory environment.
- Assists with any additional job responsibilities or tasks based on business or departmental needs, as assigned by management.
- B.S. degree/equivalent with 5+ years’ working experience, or M.Sc. degree/equivalent with 2+ years’ experience or Ph.D. degree in relevant field, or an equivalent combination of education, training, and experience as deemed appropriate by management
- Able to conduct lab work independently using established routines and procedures
- Good understanding of GLP (FDA, EPA and OECD) and GCP regulations (as applicable), as well as 21 CFR Part 11 (electronic records and electronic signatures)
- Ability to work effectively in a team
- Experience with instruments, assays and techniques commonly used in the work performed by the department
- Ability to use computers and software including Windows Operating System and Microsoft Office.
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