QC Analytical Chemist

Position Summary

The QC Analytical Chemist performs, reviews, and supports chemical and instrumental testing of raw materials, in-process samples, finished products, stability samples, and other laboratory samples in accordance with approved specifications, analytical methods, SOPs, cGMP requirements, and applicable regulatory standards.

The QC Anlytical Chemist provides technical guidance to QC analysts and supports laboratory investigations, analytical method activities, stability programs, instrument qualification, and regulatory inspections.

Essential Duties and Responsibilities

• Operate, maintain, and troubleshoot analytical laboratory instrumentation, including:
• • HPLC/UPLC
  • Gas Chromatography (GC)
  • ICP
  • UV-Visible Spectrophotometer
  • FTIR
  • Karl Fischer TitratorPerform and review chemical and instrumental analysis of raw materials, in-process samples, finished pharmaceutical products, stability samples, and other laboratory samples as required.
• Perform testing in accordance with approved specifications, compendial methods, validated analytical methods, SOPs, and laboratory procedures.
• Execute and review analytical method validation, method verification, and method transfer protocols and reports.
• Provide technical support for analytical method development, optimization, and troubleshooting.
• Ensure analytical methods and laboratory practices comply with applicable FDA regulations, USP, ICH guidelines, and other applicable compendial or regulatory requirements, including EP and BP when applicable.
• Review analytical data, chromatograms, calculations, laboratory notebooks, worksheets, electronic records, and test reports for accuracy, completeness, and compliance with approved procedures.
• Perform second-person or technical review of analytical testing performed by QC analysts, as assigned.
• Prepare, review, and revise laboratory documentation, including:
• • SOPs
  • Specifications
  • Analytical methods
  • Protocols
  • Validation and verification reports
  • Stability protocols and reports
  • Laboratory investigations
  • Deviations
  • Technical reports
• Initiate and participate in laboratory investigations involving Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, or questionable analytical results.
• Assist with root-cause investigations and development and implementation of appropriate corrective and preventive actions (CAPA).
• Ensure laboratory activities are performed in compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices, Good Documentation Practices (GDP), and established data integrity requirements.
• Maintain complete, accurate, contemporaneous, attributable, and traceable laboratory records in accordance with applicable data integrity principles.
• Train, mentor, and provide technical guidance to QC analysts and junior chemists.
• Assist with scheduling and prioritization of laboratory activities to ensure timely testing of raw materials, in-process samples, finished products, stability samples, and other priority samples.
• Monitor and support instrument calibration, qualification, preventive maintenance, and performance verification activities.
• Ensure laboratory instruments are maintained in a qualified and calibrated state prior to use.
• Maintain appropriate control of laboratory reagents, solutions, standards, reference standards, columns, and other critical laboratory materials.
• Prepare, standardize, document, and monitor laboratory reagents and solutions as applicable.
• Conduct and review stability testing in accordance with approved stability protocols, SOPs, and applicable regulatory requirements.
• Review stability data for trends, OOT results, significant changes, and other potential product quality concerns.
• Prepare and review stability summaries, trending reports, and technical reports as required.
• Participate in laboratory deviations, change controls, CAPA, investigations, and continuous improvement activities.
• Support qualification and implementation of new laboratory equipment and analytical technology.
• Assist Quality Assurance and other departments with technical evaluation of laboratory-related quality issues.
• Support internal audits, customer audits, regulatory inspections, and FDA inspections by providing analytical documentation, technical explanations, and laboratory records as requested.
• Maintain laboratory areas in an inspection-ready condition.
• Ensure compliance with applicable laboratory safety requirements and proper handling and disposal of chemicals and laboratory waste.
• Perform other Quality Control and laboratory-related duties as assigned.

Minimum Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
• Minimum of 5 years of Quality Control analytical laboratory experience in a pharmaceutical, OTC drug, or similarly regulated manufacturing environment.
• Strong hands-on experience with HPLC, GC, ICP, and other analytical instrumentation.
• Experience with analytical method validation, verification, transfer, troubleshooting, and laboratory investigations.
• Working knowledge of 21 CFR Parts 210 and 211, USP requirements, cGMP, GDP, and applicable ICH guidelines.
• Experience investigating OOS/OOT laboratory results.
• Strong technical writing, documentation review, analytical problem-solving, and communication skills.

Preferred Qualifications

• Experience in an FDA-regulated OTC drug manufacturing environment.
• Experience with HPLC, GC, ICP, FTIR, UV-Vis, Karl Fischer, and TOC instrumentation.
• Experience supporting FDA inspections and customer or third-party audits.
• Experience with stability programs and stability-indicating analytical methods.
• Experience training or mentoring QC analysts.
• Familiarity with electronic laboratory systems, chromatography data systems, and applicable data integrity requirements.

InSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experience rapid growth and can offer boundless opportunities for growth.