Chemist II

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The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.

Scope of Authority –

• Conducts laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Uses laboratory software for analyses
• May review and approve laboratory test data and documentation for completeness and compliance
• Is alert to and detects abnormalities during performances of tests and reviews
• May perform lab methods transfer and participate in method validation/verification studies
• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
• Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
• Learns to troubleshoot instrument/chromatography problems

• With guidance, participates in OOS/OOT/NOE and other investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
• May draft, edit and review SOPs and laboratory investigations

• Maintains assigned training records current and in-compliance
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

• Performs assigned work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting
• Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Follows internal processes related to controlled substances

• Follows EH&S procedures to ensure a safe work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

• Bachelor of Science Degree in chemistry, chemical engineering or related field with 2+ years’ relevant analytical laboratory experience OR
• Master’s Degree in above disciplines with 1+ years’ relevant analytical lab experience preferred

• Demonstrated proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
• Has demonstrated competence in conducting chemical analyses
• Good knowledge of wet chemistry techniques
• In-depth working knowledge of laboratory software and chromatographic software (e.g. Waters Empower, Agilent Chem Station and Sotax Win Sotax)
• Competency in Microsoft Office Suite

• Ability to display and analyze data in a logical manner
• Good verbal and written communication skills as well as good computer skills
• Attention to details and accurate record keeping
• Establish and maintain cooperative working relationships with others
• Solid organizational skills
• Ability to train less senior staff and develop laboratory skills and ability
• Ability to take initiative, set priorities and follow through on assignments

• Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate…