Education Requirements:
B.S. degree in Chemistry, Biology, Engineering or other STEM related field.
Required Skills:
Knowledge of continuous improvement principles (e.g. 5S, Kaizen, Hoshin, Standard Work).
Knowledge of routine operation of laboratory equipment including but not limited to: Karl Fisher, pH meter, conductivity meter, UV, HPLC, Dissolution apparatus, etc.
Knowledge of regulatory, cGLP principals and cGMP principles.
Experience using Microsoft Office applications (word, excel, outlook).
Preferred Skills:
- Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
- Experience utilizing Empower.
- Experience utilizing Labware/LIMS.
- Experience performing root cause analysis.
- Technical writing, including but not limited to: updating of standard operating procedures and writing quality notifications.
- Knowledge of Tier processes.
- Experience executing continuous improvement principles (e.g. 5S, Kaizen, Hoshin, Standard work).
Responsibilities:
Primary responsibilities are routine laboratory analytical testing, documentation, and reporting of potent and non-potent pharmaceutical drug product and drug substances; including but not limited to dissolution, assay/degradate, content uniformity, and identity testing in a GMP laboratory. Additional responsibilities include participating in laboratory investigations, root cause analysis, simple troubleshooting instrumentation issues, and participation in the daily tier process.
Screenings:
This position will require Beta Lactam screening, and an Eye Exam.