Job Description
Job Description
POSITION SUMMARY
Under limited supervision, the Chemist II is responsible for performing routine analytical testing, method validation/transfer activities, preparing technical documentation, and maintaining laboratory equipment in the quality control analytical laboratory.
RESPONSIBILITIES
- Perform routine laboratory testing (i.e., HPLC, UV-Vis, FTIR, CE, KF Titration, INSTRON, osmolality, pH, color/clarity, CCIT, particulate matter, wet chemistry) including finished product release, stability studies, and raw materials, following SOPs and GMP requirements.
- Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed.
- With guidance, author and execute protocols for method transfer, qualification, and validation.
- Create data summaries and author technical reports.
- Develop and revise SOPs, as needed.
- Train and guide junior chemists.
- Perform QC peer-review of laboratory raw data for basic tests.
- Calibrate, maintain, and troubleshoot various basic analytical instruments, such as osmometers, pH/conductivity meters, balances, plate readers, etc.
- Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc., with guidance.
- Initiate problem-solving for technical issues commensurate with level of experience.
- Assist with the implementation of new equipment, instruments, and software.
- Support quality system activities, such as deviation investigations and laboratory OOS/OOT investigations.
QUALIFICATIONS AND EXPERIENCE
- Bachelor’s or advanced degree in analytical chemistry, biochemistry, or a related field
- 4+ years (with Bachelor’s) or 2+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products.
- Hands-on experience with HPLC, UV-Vis, and other common analytical equipment and techniques.
- Experience executing method validations and method transfers.
- Proficiency with Microsoft Office and laboratory software for data collection and analysis. Experience with Chromeleon CDS is preferred.
- Knowledge of ICH, USP, Ph. Eur., and other regulatory and quality guidelines preferred.
- Effective communication skills, both written and verbal, for interaction with staff and vendors.