About the role
Description
Job Summary
This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products.
Responsibilities
- Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements.
- Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations.
- Document all laboratory testing and maintain accurate and legible notebooks and records.
- Peer review of data, reports and notebooks.
- Other projects and duties as assigned.
- Experience/Education Requirements: BS Degree in Chemistry or related field
- AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment
- BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment
- Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
- Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations)
- Excellent oral and written communication skills
- Strong organization and time management skills
- Demonstrated ability to work as part of a cross-functional team
Working knowledge of Microsoft Word and Excel
- Experience with software associated with a Laboratory Information Management System (LIMS)
- Work mainly performed in lab
- Stand for extended periods of time in a laboratory setting
Wear Personal Protective Equipment (PPE) as needed
Work with hazardous chemicals as needed to complete laboratory testing