**Job Description Summary** Professional Summary Experienced Quality Control Analyst with over 10 years in pharmaceutical manufacturing, specializing in analytical instrumentation, calibration, and qualification. Proven expertise in ensuring compliance with GMP, GLP, and regulatory standards. Skilled in managing laboratory operations, troubleshooting instruments, and supporting audits with accurate documentation. Strong track record of delivering timely analytical support to production and R&D teams. **Job Description** **Professional Summary** Quality Control Analyst with over 10 years of experience in pharmaceutical manufacturing, specializing in analytical instrumentation, calibration, and qualification. Demonstrated expertise in ensuring compliance with GMP, GLP, and international regulatory standards. Skilled in laboratory operations, instrument troubleshooting, and audit support with precise documentation. Proven ability to deliver timely analytical support to production and R&D teams while maintaining high standards of quality and compliance. **Key Skills** + **Analytical Instrument Handling** : HPLC, UPLC, GC, UV-Vis Spectrophotometer, FTIR, Dissolution Apparatus, Karl Fischer, Particle Size Analyzer, LCMS. + **Calibration & Qualification** : IQ/OQ/PQ of instruments, preventive maintenance, vendor coordination, and certificate verification. + **Quality Systems** : GMP, GLP, ICH guidelines, FDA compliance. + **Documentation & Reporting** : SOP preparation, logbook maintenance, deviation handling, and audit readiness. + **Method Development & Validation** : Analytical method transfer, validation protocols, and stability studies. + **Team Collaboration** : Training and mentoring junior analysts, coordinating with QA, production, and regulatory teams. + **Special Responsibilities** : + Working standard qualification analysis + Calibration of Dissolution, HPLC, UPLC, LCMS, and GC as per schedule + API analysis + Standard, column, and chemical management + Instrument qualification for new equipment + Standard website review and updates **Professional Experience** **Senior QC Analyst** _Pharmaceutical Manufacturing Company_ _2015 – Present_ + Oversaw handling, maintenance, and calibration of all analytical instruments in the QC laboratory. + Conducted routine and non-routine analysis of raw materials, intermediates, and finished products. + Executed instrument qualification (IQ/OQ/PQ) ensuring compliance with regulatory standards. + Supported internal and external audits with accurate documentation and timely responses. + Supervised and trained junior analysts in GMP practices and instrument operation. + Coordinated with QA for archival of logbooks and review of analytical records. **QC Analyst** _Pharmaceutical Manufacturing Company_ _2010 – 2015_ + Performed analytical testing using HPLC, GC, UV, and other instruments. + Maintained daily usage logbooks and ensured timely review and approvals. + Assisted in method validation and analytical method transfer activities. + Participated in equipment qualification and calibration schedules. + Ensured strict adherence to SOPs and laboratory safety protocols. **Education** + **M.Sc. in Chemistry / Pharmaceutical Sciences / M.Pharm** + Certifications in **GMP, GLP, and Instrument Calibration** (if applicable). **Achievements** + Successfully led multiple equipment qualification projects with zero audit observations. + Maintained 100% compliance in calibration schedules for five consecutive years. + Key contributor in method transfer projects between R&D and QC. + **Additional Responsibilities** : + Working standard qualification analysis + Calibration of Dissolution, HPLC, UPLC, LCMS, and GC as per schedule + API analysis + Standard, column, and chemical management + Instrument qualification for new equipment + Standard website review and updates All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.