Specialist, Analytical Technical Services
hace 1 día
North Brunswick
Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Specialist ,Analytical Technical Services Department Quality Control Reports to Manager, Analytical, R&D, & Method Validation FLSA (Exempt or Non-Exempt Non- Exempt Role Overview The Analytical Technical Services Specialist supports the QC Analytical function in the development, assessment, verification, validation, transfer, and optimization of analytical methods for nutraceutical products, raw materials, intermediates, and finished products. This individual serves as a technical resource for analytical methods, laboratory instrumentation, testing practices, and troubleshooting, working closely with the QC Analytical Manager and laboratory personnel to ensure methods are scientifically sound, appropriately documented, and aligned with applicable compendial and quality requirements. The position combines hands-on laboratory work with independent technical responsibility for complex analytical activities. Areas of Responsibility Key Responsibilities • Work with the QC Analytical Manager and QC Analysts to assess, create, develop, verify, validate, transfer, and optimize analytical methods., • Serve as a technical resource and subject matter expert for analytical methods, laboratory instrumentation, testing practices, and analytical troubleshooting., • Perform and support complex analytical testing of raw materials, in-process materials, finished products, stability samples, and other materials as required., • Perform testing using QC laboratory instrumentation, including HPLC/UPLC, GC, IR/FTIR, UV-Visible spectrophotometers, dissolution equipment, Karl Fischer titrators, auto titrators, potentiometers, and other applicable instruments., • Independently prepare, review, and execute analytical method validation and verification protocols, including preparation and review of final summary reports., • Evaluate analytical methods against applicable validation characteristics, including accuracy, precision, specificity, linearity, range, robustness, and system suitability., • Support analytical method development, verification, validation, transfer, and ongoing method suitability assessments to ensure consistent and reliable results., • Troubleshoot complex HPLC, GC, analytical method, testing, and instrument-related issues; identify potential root causes and recommend appropriate corrective actions., • Review and interpret chromatograms, calculations, system suitability results, raw data, and analytical documentation for accuracy, completeness, consistency, data integrity, and compliance with approved procedures., • Lead or support investigations involving Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, atypical or unexpected results, analytical deviations, customer complaints, product quality concerns, and instrument- or method-related issues., • Support laboratory investigations, root cause analysis, and Corrective and Preventive Actions (CAPA), ensuring that conclusions and follow-up actions are technically sound and appropriately documented., • Review applicable USP–NF and other relevant pharmacopoeial or compendial requirements; assess method updates and support their implementation, verification, and ongoing compliance., • Develop, review, and improve analytical test methods, SOPs, specifications, protocols, worksheets, reports, investigation records, and other technical documentation., • Support analytical method transfers between R&D, QC, manufacturing sites, customers, and external laboratories, as applicable., • Provide technical guidance, troubleshooting support, knowledge sharing, and mentoring to QC Chemist I, QC Chemist II, and other laboratory personnel. Assist with training on methods, instrumentation, laboratory practices, and troubleshooting., • Provide technical input for the evaluation and implementation of new analytical instruments, laboratory equipment, and testing technologies., • Partner with Quality Assurance, Manufacturing, R&D, Regulatory, and other cross-functional teams on analytical and product-quality initiatives., • Support internal audits, customer audits, and regulatory inspections by providing technical information and analytical documentation as needed., • Identify opportunities to improve laboratory processes, analytical methods, testing efficiency, equipment utilization, and overall laboratory operations., • Maintain compliance with cGMP, FDA requirements, applicable compendial standards, data integrity requirements, laboratory safety procedures, and company policies., • Provide regular updates to the QC Analytical Manager on project status, testing activities, results, risks, and timelines; promptly communicate technical problems, delays, unexpected results, or resource constraints that may affect completion or product testing., • Maintain accurate, complete, and traceable laboratory records and ensure analytical activities are appropriately documented., • Perform other duties and responsibilities as assigned by management. Other Responsibilities, Including Safety • Work safely and responsibly to promote and maintain an injury-free and incident-free workplace., • Comply with applicable safety policies, laboratory safety procedures, GMP requirements, and job-related training requirements., • Use required personal protective equipment (PPE) and follow established procedures for handling chemicals, laboratory equipment, and hazardous materials., • Promptly report safety concerns, incidents, unsafe conditions, equipment issues, or other potential hazards to management., • Maintain a clean, organized, and safe laboratory work environment., • Keep management informed of area activities, project status, significant technical issues, delays, and other problems that may impact laboratory operations or product quality. Requirements Education & Qualification: Recomendation • Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline., • Demonstrated experience independently executing analytical method validation, method transfer, and laboratory investigations., • The 5–7 years of relevant experience is important because this is an individual technical specialist position expected to independently manage complex analytical activities and provide technical guidance to other QC chemists., • Experience in analytical chemistry within a pharmaceutical, nutraceutical, dietary supplement, food, or other regulated manufacturing/CDMO environment., • Experience with HPLC/UPLC, GC, FTIR/IR, UV-Vis, titration, Karl Fischer, dissolution, or similar analytical instrumentation., • Strong understanding of GMP laboratory practices, data integrity, laboratory investigations, and analytical documentation., • Demonstrated ability to troubleshoot complex analytical and instrumentation issues., • Strong technical writing, communication, organization, and problem-solving skills., • Ability to work independently while collaborating effectively with QC, QA, R&D, Manufacturing, and other departments. Certifications, Licenses, Credentials: • N/A, • Relevant professional certifications in analytical chemistry, laboratory science, GMP, or quality systems are preferred but not required., • certifications in analytical method development, validation, verification, USP–NF compendial requirements, and cGMP. Skills & Abilities • Strong knowledge of analytical chemistry principles, laboratory practices, and analytical testing techniques., • Hands-on experience with analytical instrumentation, including HPLC/UPLC, GC, FTIR/IR, UV-Visible Spectrophotometer, Karl Fischer, dissolution, auto titrator, and potentiometer., • Strong understanding of analytical method development, validation, verification, transfer, and optimization., • Ability to troubleshoot complex analytical methods, laboratory equipment, and instrument-related issues., • Ability to lead or support investigations involving OOS, atypical results, deviations, customer complaints, and product quality concerns., • Knowledge of USP/compendial requirements and their application to analytical testing., • Strong understanding of cGMP, FDA requirements, data integrity, laboratory safety, and quality systems., • Strong technical writing skills, including the ability to prepare protocols, reports, SOPs, test methods, investigations, and other technical documents., • Strong analytical, problem-solving, and root-cause analysis skills., • Ability to interpret analytical data and identify trends, inconsistencies, and potential laboratory issues., • Ability to manage multiple projects, prioritize activities, and meet established deadlines., • Strong verbal and written communication and interpersonal skills., • Ability to provide technical guidance, training, and mentoring to other QC laboratory personnel., • Ability to work independently while effectively collaborating with QC, QA, R&D, Manufacturing, and other cross-functional teams., • Strong attention to detail and commitment to accuracy, data integrity, and documentation., • Ability to identify opportunities for continuous improvement, laboratory efficiency, and analytical process optimization., • Ability to work effectively in a fast-paced nutraceutical CDMO environment and adapt to changing priorities. Preferred Technical Experience Experience with analytical instruments and software such as: • Shimadzu LC2010, • Shimadzu Nexera, • GC2010, • Thermo ICP-MS, • Shimadzu LabSolutions or other Laboratory Data Acquisition Systems, • Analytical method development and validation, • Method verification and transfer