Proactively perform QC function in full compliance with cGMP

·       Proactively perform QC function in full compliance with cGMP.

·       Oversee / conduct the transfer of validated methods from Method Development group to Quality Control laboratory.

·       Performing analyses using qualified/validated analytical methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.

·       Keep good lab record and maintain GMP documentation.

·       Schedule workflow and supervise other QC Analysts.

·       Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product, and stability samples.

·       Troubleshoot, maintain, procure and install various analytical instruments.

·       Actively participate on cross functional improvement initiatives.

·       Conduct lab Out Of Specification (OOS), Out Of Tolerance (OOT) investigations, and material non-conformance investigations.

·       Conduct hands-on training for all QC chemists and technicians.

·       Maintain the laboratory in compliance with the company’s cGMP and Environmental Health and Safety (EH&S) procedures.

·       BS/MS in chemistry major with minimum 4 years of pharmaceutical experiences, preferably from QC function in CDMO setting.

·       Working knowledge with USP procedures, ICH guidelines, and regulatory guidelines.

·       Hands-on experiences in the analysis of small molecule pharmaceutical API and/or ingredients

·       Proficiency in operating analytical instrumentations, such as HPLC, LC/MS, GC, GC/MS, TOC, UV-vis, Particle size analyzer and wet chemistry under GMP guideline.

·       Must enjoy the dynamic and fast-paced CDMO environment,

·       A team player that cherishes the collaborative working relationship while maintaining individual accountability

·       Ability of multitasking and prioritizing under stringent timeline

·       Excellent communication abilities along with good document practices.