QC Chemist III

Job Description
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.

Company

Anchen Pharmaceuticals

Job Code

State or Province

California

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