The Chemist I is responsible for performing all the analytical testing related to raw materials, compounding activities, and final product testing including HPLC analysis in the Chemistry laboratory. Other responsibilities include sampling, testing, and releasing of utilities.
- Tier 1 Products
- Wet Chemistry
- HPLC Beginner
- GC Beginner
Performing chemical raw material (sampling, testing and release), in-process (including product formulation activities), and final product including stability and complaint sample testing.
Responsible for performing all chemical tests associated with validations, such as cleaning process or equipment validations.
Assist in performing method transfer when requested.
Responsible for peer review or review when requested.
Notify QC Laboratory Manager immediately of out of specification results and assist in the investigations of OOS and deviations as requested by the QC Laboratory Management.
Assist in special projects and regulatory audits as requested by the QC Laboratory Management.
Assist in collaboration of laboratory SOPs when requested.
Responsible for ensuring new logbooks are acquired and coordinating documents ready for off-site storage to include documents located in the file cabinets.
Responsible for assisting with method transfers when requested.
Responsible for assisting with training when requested.
Responsible for ensuring inventory is performed and assisting with ordering when requested.
Responsible for ensuring that routine maintenance of instrumentation is performed as stated in the instrument manual and contacting the manufacturer for assistance when needed.
Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment.
Follow Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines.