Support QC Stability and Analytical laboratory operations; table generation and review, stability time point pulls, sample receipt and shipment, routine sample testing and general laboratory tasks.
Log, track, receive/ship samples for laboratory testing or other purposes.
Perform sample login and prepare test requests as needed.
Assist with collation and review of data tables.
Assist with trending of data.
Assist with coordination and management of control/reference standard program.
Author and revise stability protocols and reports.
Author and revise SOPs.
Conduct routine analysis of samples to support release and stability testing and any study as needed.
Support general laboratory functions, i.e., reagent receipt, prepare solutions, ensure reagent and solution expiration status, assist in laboratory cleaning activities and receive/ship samples according to designated procedures.
Maintain, monitor and calibrate/standardize lab equipment, ensure equipment calibration status.
May participate in method validations, including protocol and report writing.
Perform analytical biochemistry techniques, including, but not limited to pH and appearance and reconstitution.
BS or BA in Biology, Biochemistry or other related scientific discipline with 0-2 years of experience.
Capability and willingness to learn new techniques.
Must be able to accurately follow written procedures and verbal instructions.
Must communicate well and exhibit a high level of professionalism.
Good time management and organizational skills with strong attention to detail.