|Job Description :
Impact of Position: The developed analytical test methods shall easily be validated. The analytical test methods shall be validated with excellent quality according to cGMP and transfer to QC department within specified timeline.Any inaccurate or insufficient validation and delay in release of samples will delay submission of applications which will significantly affect the Company’s ability to compete in the market place.
Essential Job Functions: Responsibilities include, but are not limited to, the following. Additional position-specific tasks might be required.
· Perform analytical method development/validation and sample analysis
· Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing which requires critical levels of accuracy.
· Manage time effectively to complete assignments in expected time frame
· Document analytical data under cGMP and corporate guidelines
· Troubleshoot instrument problems under occasional supervision.
· Evaluate process changes and troubleshoots analytical problems as they arise
· Write and review analytical test methods, validation protocols and reports
· Review lab testing results and notebooks to ensure accurate documentation
· Keep the training record related to the job functions up to date and make sure one received proper training before performing any tests.
· Provide general laboratory support; such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
· Maintain the R&D lab a GMP and safe working environment
· Assist lab management for other temporary assignments
· Functions under supervision as well as perform independent scheduling
Job Requirements :
Required Knowledge and Skills:
· Ability to multi-task and work independently and as part of a team, self-motivation, adaptability, and a positive attitude
· Capable of operating laboratory equipments and performing testing using techniquessuch asHPLC, GC, UV, Dissolution, FTIR, pH meter,and TLC.
· Hand-on experience in basic wet chemistry techniques and knowledge of analytical development, validation, analytical instrumentation, stability.
· GMP proficient, attention to details and accurate record keeping. Experience in documenting compliance
· Excellence inter-personnel skill for communication and working with people
· Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
· Proficient computer skills
· BS degree in chemistry, biology, biochemistry or equivalent education background
with 7 plus years experience in Pharmaceutical Industry or
· MS degree in chemistry, biology, biochemistry or equivalent education background with 5 plus years analytical experience in Pharmaceutical Industry or
· Ph.D. degree in chemistry, biology, biochemistry or equivalent education background with 3 plus years analytical experience in Pharmaceutical Industry in the aspect of at lease one of the following area (raw material, stability, method validation or product release)
State or Province