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Speed Laboratory, Inc

Senior Analytical Chemist

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Job Description

Job Summary The Senior Analytical Chemist performs analytical testing in support of pharmaceutical, dietary supplement, personal care, and other regulated products in a contract laboratory environment. The position utilizes chromatographic, spectroscopic, and general analytical techniques, including HPLC, GC, UV-Vis, and FTIR. The Senior Analytical Chemist is responsible for independently performing assigned laboratory work, accurately documenting testing and observations, reviewing and interpreting analytical data, troubleshooting analytical issues, and completing work in accordance with approved methods, SOPs, protocols, and applicable GMP and regulatory requirements. Experience with method development, method validation/verification, GC-MS, ICP-MS, or other advanced analytical instrumentation is highly desirable. Major Responsibilities Perform routine and non-routine testing of a variety of sample types using HPLC, GC, UV-Vis, FTIR, wet chemistry, and other applicable analytical techniques. Independently execute compendial, client, and laboratory analytical methods in accordance with approved procedures and GMP requirements. Prepare samples, standards, reagents, mobile phases, and other laboratory solutions required for analytical testing. Review analytical data for accuracy, completeness, consistency, and compliance with applicable procedures. Evaluate chromatographic and analytical results and identify unexpected, atypical, OOS, or OOT results requiring further evaluation. Troubleshoot analytical methods, instrumentation, and testing problems within the chemist's area of experience and training. Participate in method development, optimization, transfer, verification, and validation activities as assigned and qualified. Maintain complete and accurate laboratory notebooks, worksheets, logbooks, forms, electronic records, and other required laboratory documentation. Prepare or contribute to analytical reports, Certificates of Analysis, protocols, summaries, and other laboratory documentation. Coordinate assigned testing with laboratory personnel and project management to support timely completion of client projects and communicate potential delays. Assist with routine maintenance, calibration, performance verification, and qualification activities for analytical instrumentation as assigned. Communicate with instrument manufacturers or technical support when necessary to assist in troubleshooting equipment issues. Provide technical assistance and guidance to less-experienced laboratory personnel within areas of demonstrated expertise. Identify practical opportunities to improve laboratory efficiency, analytical quality, and reliability. Follow all applicable safety, quality, regulatory, and company requirements. Complete and maintain training required for assigned laboratory duties. Perform work in accordance with company SOPs, approved methods and protocols, and applicable GMP, compendial, FDA, ICH, and other regulatory requirements. Perform other laboratory-related duties consistent with the position as assigned. Required Qualifications Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field. Approximately 3-5 years of relevant analytical laboratory experience, or an equivalent combination of education and experience. Demonstrated hands-on experience with HPLC, GC, UV-Vis Spectrophotometry, FT-IR and other commonly used analytical laboratory techniques. Ability to independently perform analytical testing and accurately interpret and document results. Experience maintaining laboratory notebooks, worksheets, instrument records, and other technical documentation. Good understanding of analytical laboratory practices, data integrity, and proper documentation practices. Strong attention to detail, analytical reasoning, and laboratory technique. Ability to troubleshoot routine analytical and instrumental problems. Ability to organize and prioritize multiple laboratory assignments while meeting project deadlines. Effective written and verbal communication skills. Working knowledge of Microsoft Excel and Word. Preferred Qualifications Experience working in a GMP-regulated pharmaceutical, dietary supplement, personal care, or contract testing laboratory. Experience with GC-MS, ICP-MS, or other analytical instrumentation. Experience with chromatographic data systems such as Empower or equivalent software. Experience with compendial testing, including USP or other recognized pharmacopeial methods. Experience with analytical method development, transfer, verification, or validation. Experience investigating analytical problems, OOS/OOT results, or laboratory deviations. Familiarity with applicable FDA, USP, ICH, and GMP requirements.
Job Type:
Full-time Pay:
$65,000.00 - $70,000.00 per year
Benefits:
Paid time off
Experience:
ICP-MS:
5 years (Required)
Work Location:
In person

Benefits

  • Paid Time Off (PTO)
  • Dental Insurance