The responsibility of the QC Chemist is to perform all chemical and physical testing required for release of raw materials, packaging components, drug substances, and drug products.
Responsibilities:
- Perform all required physical, chemical and microbiological testing activities, in support of Quality Control, Manufacturing, Research and Development and Quality Assurance, with respect to raw materials, in-process materials, finished product, stability studies and some special projects. May also be required to assist/support method and process validation, method qualifications and verifications when required.
- Perform, as required, in the absence of appropriate personnel, the responsibilities of sampling and physical testing of raw materials and packaging components, as needed.
- Assist, with the help of other personnel, various QC functions including validation, stability studies, and calibration program.
- Comply with all safety requirements, order chemicals and laboratory supplies on time, perform laboratory waste pickup and drop-offs on a weekly basis, and take part in other laboratory chores as instructed by Laboratory Supervisor or Director.
- Assist, as delegated, in the writing of Standard Operating Procedures (SOPs) for instrument/equipment operation and testing methods.
- Maintain in a precise, up-to-date order, all laboratory calibration, repair and usage logs, notebooks, charts and other record-keeping devices.
- Maintain the QC laboratory in a clean, orderly and organized manner.
- Perform other duties as assigned by Lab Supervisor, Director and/or VP of Quality Control.
Qualifications:
- Minimum Bachelor’s degree in Chemistry, or any scientific discipline, with zero to two (2) years’ experience or an Associate’s degree within a scientific discipline with at least five (5) years of experience within the pharmaceutical, environmental, health care or chemical arena having performed analytical chemistry, method development and validation, stability and chemical testing.
- Some knowledge and experience in cGMPs, GLP, USP/NF testing and laboratory instrumentation (e.g. HPLC, GC, IR, UV/VIS, TOC, AA) for the analysis of drug dosage forms may be required.
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