Cranbury, NJ 08512
- Perform routine and non-routine analysis on raw materials, drug substances, reference material and drug products using a variety of instrumental and wet chemistry techniques.
- Conducts calibration, qualification and maintenance of laboratory instrumentation (i.E., pH meter, HPLC, dissolution equipment, etc.).
- Operates and maintain general analytical instruments (i.E., HPLC, dissolution apparatus, UV, IR, KF titrator, Coulometer, etc.).
- Develop and validate test methods as required.
- Performs wet Chemistry tests on raw materials, in process samples and finished products.
- Prepares standard and sample solutions as required by the test methods.
- Maintains appropriate documentation (records and lab notebooks) as required by SOP s.
- Complies with all current Good Manufacturing Practices (cGMP) and safety requirements, Standard Operating Procedures (SOPs) and company policies and procedures.
- Complies with good housekeeping and safety practices.
- Participates in troubleshooting of analytical test methods and laboratory instruments.
- Performs related duties as assigned.
- Takes part in the training program as a qualified trainer, as requested.
- Assist in other parts of the department as workload and project priorities dictate.
- Assists in reviewing test methods.
- Perform analysis on intermediate and finished product
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Up-to-date instrumentation and the following instruments: UV/IR, HPLC and TLC.
- Chemistry and wet chemistry.
- Computer applications and programs related to laboratory applications such as HPLC, FTIR, TOC analyzer etc.,
- Sampling methods and quality control systems.
- Mathematics including statistics.
- Sample preparation techniques.
- Spectroscopic techniques and chromatographic system.
- Must have basic computer knowledge, including MS Excel, Word, and Outlook.