QC Chemist I

Chemist III

Responsibilities: <ul><li>The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.</li><li>May participate in investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.</li><li>Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>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.&nbsp;</li><li>Uses laboratory software for analyses.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping</li><li>Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.</li><li>May assist in drafting, editing, and reviewing SOPs and laboratory investigations.</li><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of less senior laboratory staff.</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances continuous.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.</li></ul> Requirements: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job.</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required.&nbsp;</li><li>Some pharmaceutical laboratory experience preferred.</li><li>Proficiency in a body of information required for the job.</li><li>e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>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.&nbsp;</li><li>Basic knowledge of wet chemistry techniques.</li><li>Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li><li>Physical &amp; mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.&nbsp;</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.</li><li>Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations.</li><li>Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.&nbsp;</li><li>Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.</li><li>Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UVVis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Uses laboratory software for analyses.</li><li>Reviews and approves laboratory test data and documentation for completeness and compliance.</li><li>Is alert to and detects abnormalities during performances of tests and reviews.</li><li>Elevates abnormalities to Supervisor.</li><li>Performs lab methods transfer and participate in method validation/verification studies</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs&nbsp;</li><li>Detects, conducts and reports on OOS/OOT/NOE and other investigations.</li><li>Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action.</li><li>Writes, edits and reviews SOPs and laboratory investigations</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures&nbsp;</li><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR,</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience.</li><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full 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.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Has demonstrated competence in conducting chemical analyses.</li><li>Strong knowledge of wet chemistry techniques.</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner.</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information.</li><li>Ability to display and analyze data in a logical manner.</li><li>Strong verbal and written communication skills as well as good computer skills.</li><li>Strong attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to coach less senior staff and develop laboratory skills and ability.</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul>

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QC Chemist I

Chemist III

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QC Chemist I

Chemist III

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