Chemistry Lab Associate II

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Job Summary

  Scientech Laboratories is seeking a motivated and detail-oriented Chemistry Lab Associate II to support analytical testing of OTC drug, pharmaceutical, and cosmetic products in an FDA cGMP-compliant analytical laboratory. The successful candidate will have hands-on experience using analytical instrumentation and knowledge of laboratory operations required to support method development, validation, verification ,stability, and release testing. Experience with cGMP documentation, and compliance activities in a regulated environment is required. Ability to occasionally support microbiology-related work is desired.

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Reports to:

Laboratory Manager

Collaborates with:

Laboratory and Quality Assurance Associates

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Roles and Responsibilities:

·      Independently run validated methods for a variety of analytical chemical analyses on laboratory instruments (LC, GC, IR, UV, dissolution, viscosity, melting point, and others).

·      Prepare samples of OTC drug, prescription pharmaceutical, cosmetic, dietary supplement, and botanical products for analysis in the above methods.

·      Process data from instruments (LC, GC, ICP-MS and others) to produce results ready for data review and QA.

·      Document experiments, analyses, and results accurately in lab notebooks or software systems in an FDA cGMP compliant manner. Ensure that all laboratory work complies with regulatory standards(e.g., FDA, DEA, ISO and internal SOP).

·      Participate in investigations, deviations, OOS/OOT, and CAPA activities

·       Maintain laboratory instruments, including calibration, routine maintenance, and troubleshooting.

·       Support method development, verification, validation, and transfer activities as assigned.

·      Adhere to laboratory safety guidelines, OSHA standards and chemical waste disposal SOP in proper handling and disposal of hazardous materials.

·      Occassionally assist with basic microbiology activities such as media preparation, sample handling, environmental monitoring, or sterility-related support as needed

Requirements:

·       Bachelor’s degree in Chemistry, Analytical Chemistry, Organic Chemistry, or related scientific discipline.

·       About 4 to 6years of work experience with HPLC and GC methods and other relevant instrumentations. Experience in working with ICP-MS, LC-MS, GC-MS is aplus.

·       Experience in working in an FDA-regulated environment, preferably cGMP is required. Familiarity with ICH guidelines, USP/EP/JP monographs is required

·      Strong attention to detail, documentation, and organizational skills. Ability to work independently and collaboratively in a fast-paced environment.

·       This is a 100% onsite position.

·       Basic understanding and hands-on experience in microbiology and aseptic techniques is a plus

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