|Job Description :
Essential Duties and Responsibilities:
· Conducts routine laboratory analyses such as finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Perform method qualification, verification or validation occasionally. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments such as HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter and analytical balance and etc.
· Work as a substitute for the QC supervisor, if necessary.
· Troubleshoot instrument problems under occasional supervision.
· Responsible for training of junior staff.
· Train junior staff in troubleshooting skills.
· Proactively provide supervisor with suggestions on how to prevent analytical error by improving the methods, lab practice or lab system.
· Conduct laboratory investigation and prepare laboratory investigation report under supervision.
· Perform notebook review to ensure accurate documentation.
· Alert to and detect abnormalities occurring during performances of tests and reviews.
· Guide junior staff in good documentation practice.
· Reports to supervisor immediately regarding OOS results and deviation from established testing procedures. Do not retest samples or re-measure samples on own decision where results are questionable.
· Keep the training record related to the job functions up to date and making sure one has 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.
· Cleans laboratory working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
· Follow all applicable safety and standards guidelines, such as company’s SOP, cGMP, DEA regulations good documentation practice and/or MSDS.
· Performs related duties as assigned.
Job Requirements :
Education and or Experience:
· Bachelor of Science Degree in chemistry, biology, biochemistry or equivalent education background from an accredited college or university is acceptable.
· 4+ years of pharmaceutical laboratory experience is preferred.
· 4+ years of hands-on experience in analytical instruments such as HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter and analytical balance and etc.
· Seasoned in wet chemistry techniques.
· Advanced knowledge in software such as Waters Empower, Agilent ChemStation and Sotax WinSotax.
· Advanced working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
· Produce analytical work with excellent quality and quantity.
· Excellent verbal and written communication skills.
· Good leadership skills.
· Attention to details and accurate record keeping.
· Establishing and maintaining cooperative working relationships with others.
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