The Chemist II is responsible for performing all the analytical testing related to raw materials, compounding activities, and final product testing in the Chemistry laboratory. Other responsibilities include sampling, testing, and releasing of utilities.
Responsible for sampling, testing, and releasing all chemical raw materials.
Responsible for performing dispensing activities.
Responsible for performing all chemical raw material, in-process, and final product testing.
Responsible for performing all chemical tests associated with product stability studies.
Responsible for performing all chemical tests associated with validations, such as cleaning process or equipment validations.
Responsible for performing method transfers.
Responsible for analysis of complaint samples.
Responsible for troubleshooting, maintenance, and calibration of laboratory equipment.
Document raw and final data to ensure complete and proper documentation according to our procedures and applicable cGMPs.
QC Reviewer of dispensing, raw material, compounding and finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks).
Responsible for practicing all applicable cGMPs/cGLPs.
Assist in the investigations of OOS and deviations as requested by the QC Laboratory Manager.
Assist in special projects and regulatory audits as requested by the QC Laboratory Manager.
Assist in writing laboratory SOPs.
Notify QC Laboratory Manager immediately of out of specification results.
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 coordinating documents ready for off-site storage to include documents located in the file cabinets.
Responsible for ensuring new logbooks are acquired.
Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment.
Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
BS degree in Chemistry or related field with 2 - 4 years experience in a QC laboratory environment.
Ability to understand/follow all applicable standard operating procedures and cGMPs/cGLPs routinely.
Proficient with current word processing, spreadsheets, and database software.
Demonstrated knowledge of standard laboratory techniques and procedures as evidenced by prior work experience or on the job training.
Ability to operate standard and advanced laboratory instrumentation as evidenced by prior work experience or on the job training.
Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within QC and between other departments.