Job Description
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
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