Responsibilities:

• Primary responsibilities are routine laboratory dissolution, assay, content uniformity, and identity testing and documentation in a GMP laboratory.
• Additional responsibilities include entering data into Labware, participating in investigation meetings and some drafting of investigations, participating in root cause analysis, simple troubleshooting instrumentation issues.

Qualifications

• Education Requirements: B.S. degree (preferably in Chemistry or Biology, will look at Engineering if applicable).

Required Skills

• Knowledge of continuous improvement principles.
• Experience operating routine laboratory equipment including but not limited to: Karl Fisher, pH meter, conductivity meter, UV, etc.
• Knowledge of regulatory and cGMP principles.

Preferred Skills

• Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
• Experience utilizing Empower.
• Experience utilizing Labware/LIMS.
• Execution of root cause analysis.
• Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications.
• Knowledge of Tier processes.
• Experience executing 5S principals.