- Location: Columbia, SC
- Type: Direct Hire
- Job #38071
The Chemist IV 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.
- Tier 1, 2, and 3 Products
- Wet Chemistry
- HPLC and UHPLCAdvanced
- ICP MS
- Product TransferAdvanced
- OOS/OOT Investigations
- 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.
- Responsible for performing method transfer assistance 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 performing method transfers.
- Responsible for assisting in training.
- Responsible for ensuring inventory is performed ordering when requested.
- QC Reviewer of dispensing, raw material, compounding and finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks).
- Responsible for assisting with training 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 and troubleshooting.
- 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.
- BS degree in Chemistry or related field with 5+ years’ experience in a QC laboratory environment
- Demonstrated knowledge of standard and advanced laboratory techniques and procedures as evidenced by work experience
- Ability to operate standard and advanced laboratory instrumentation and troubleshooting as evidenced by work experience
- Ability to train and mentor other chemist in standard and advance laboratory techniques
- Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within QC and between other departments