QC Scientist, Analytical

Perform analytical testing, method development, validation, and instrument operation to support product development, quality control, and regulatory compliance for multiple dosage forms within a cGMP/GLP pharmaceutical environment. Perform quality control testing for inprocess materials, finished products, and stability samples across multiple dosage forms, including oral solids, topical formulations, and transdermal systems. Conduct analytical testing, including assay, related substances/impurities, blend and content uniformity, particle size analysis, dissolution testing, and residual solvent analysis using appropriate methodologies. Operate analytical instruments, including HPLC, UPLC, GC, particle size analyzers, dissolution apparatus, FTIR, UVVis spectrophotometer. Perform instrument maintenance, calibration, and troubleshooting to ensure accuracy, reliability, and compliance with laboratory requirements. Develop analytical methods, including particle size determination using laser diffraction techniques, and conduct method validation for various dosage forms in accordance with USP/FDA guidelines in a cGMP/GLP environment. Evaluate QbD batch formulations by performing complete analytical testing to assess formulation characteristics and quality attributes. Maintain accurate laboratory notebooks and prepare ARD/QC reports in compliance with documentation and data integrity requirements. Conduct investigations and deviation experiments under group leader supervision, document observations and prepare reports as needed. Respond to data reviews and provide professional support for audit responses, ensuring timely and compliant follow through. Comply with all applicable SOPs and laboratory procedures to ensure adherence to regulatory and internal quality standards. Perform QC testing using the LIMS system for sample management, data entry, and results reporting. Applicant must have a Master's degree (or U.S. equivalent) in Chemistry, Pharmacy, or Pharmaceutics. Two (2) years of work experience in Analytical R&D and Quality Control within the pharmaceutical industry. Applicants must have: Experience supporting OOS/OOT investigations and deviations in raw materials and finished products. Hands-on experience supporting and coordinating regulatory inspections, including: USFDA, MHRA, TGA, ANVISA, and WHO audits. Strong understanding and execution of cGMP documentation practices, laboratory compliance, and GLP monitoring. Hands on experience with analytical instruments (HPLC, GC, FT IR, dissolution, particle size analysis, KF titration, autotitrator, polarimeter) and proficiency with analytical software (Empower, Chromeleon, LabSolutions, LabWare LIMS) is required. Must have demonstrated experience in developing and validating analytical methods, and in preparing method development reports, validation protocols, validation reports, and standard test procedures. Experience handling various pharmaceutical dosage forms, including but not limited to oral solids (immediate and modified release), topicals (ointments, gels, creams, lotions, and solutions), and injectables, is required. Applicants must have subject matter expertise in FDA requirements and demonstrate the ability to understand and follow these requirements during analytical testing. Experience using LIMS systems for testing, documentation, and data management is required.