Bhaskar Muttineni

Detail-oriented and experienced QC Chemist with 5 years of hands-on experience in quality assurance and quality control within GMP-regulated industries. Proficient in analytical testing, document control, regulatory compliance, and data review. Skilled in handling raw materials, intermediates, finished products, and stability samples using advanced laboratory instruments.

Strong understanding of GMP documentation, audits, and laboratory investigations, with a focus on maintaining accuracy and compliance with FDA regulations.

Senior QA/QC Analyst at NAN TECHNOLOGIES (2024-01 – Present)

• Perform advanced trace metal analysis of drinking water and environmental samples using ICP-MS and ICP-OES, ensuring high sensitivity detection and compliance with EPA methodologies.
• Apply strong expertise in sample preparation, digestion, and extraction techniques to support accurate and reproducible analytical results across varying sample matrices.
• Review and validate analytical data, calibration curves, and QC results (blanks, spikes, duplicates) to ensure adherence to quality assurance/quality control (QA/QC) standards and data integrity requirements.
• Support and enforce SOPs, calibration protocols, and preventive maintenance schedules for analytical instrumentation, ensuring consistent performance and regulatory compliance.
• Collaborate with laboratory teams to identify process improvements and optimize workflows, increasing efficiency in sample throughput and reporting timelines.
• Contribute to maintaining a regulated laboratory environment aligned with ISO 17025 principles, including documentation control, traceability, and audit readiness.
• Utilize LIMS systems for sample tracking, data management, and reporting, ensuring complete chain-of-custody and real-time data visibility.
• Assist in training and supporting junior analysts and technicians on laboratory procedures, documentation practices, and instrument operation.
• Performed instrument tuning, calibration, and performance verification of ICP-MS systems to ensure optimal sensitivity, accuracy, and stability.
• Manage sample intake, labeling, and inventory control processes to ensure efficient laboratory operations and uninterrupted analytical workflows.
• Reviewed analytical data, logbooks, and batch records for completeness, accuracy, and adherence to internal QA standards and regulatory requirements.
• Supported method detection limit (MDL) and limit of quantitation (LOQ) studies for trace metals in water samples.
• Conducted continuing calibration verification (CCV) and initial calibration verification (ICV) to maintain analytical accuracy and compliance.
• Evaluated method blanks, laboratory control samples (LCS), matrix spikes (MS/MSD), and duplicates to ensure data validity in environmental testing.
• Supported audit readiness and compliance for environmental testing laboratories through proper documentation and traceability of water sample analysis.

QC Chemist at ALVEUS PHARMACEUTICALS (2020-01 – 2023-12)

• Sampling and testing of raw materials, intermediates, and finished products using current pharmacopoeias (IP, USP), wet chemistry techniques and instrumental methods.
• Performed routine QC tests including assay, related substances, uniformity of dosage units, disintegration, friability, average weight, dissolution, sulphated ash, loss on drying (LOD), melting point, thin-layer chromatography (TLC), and pharmacopoeia limit tests.
• Operated and calibrated analytical instruments such as UV-Vis spectrophotometer, FTIR, HPLC, Karl Fischer, ICP-MS, ICP-OES, Dissolution Apparatus, pH meter, conductivity meter, polarimeter, viscometer, refractometer, and density meter.
• Followed validated analytical methods and ensured compliance with IP and USP standards throughout testing procedures.
• Managed CAPA activities, including investigation, corrective actions, and effectiveness verification.
• Documented all test results accurately in analytical worksheets, logbooks, and controlled formats, adhering to ALCOA+ principles.
• Prepared and revised SOPs, product specifications, and laboratory procedures in support of regulatory and quality system requirements.
• Ensured strict adherence to current Good Manufacturing Practices (cGMP) and laboratory safety guidelines (EHS/COSHH).
• Supported internal audits and external regulatory inspections by maintaining audit-ready documentation and analytical records.
• Practiced safe chemical handling, proper labeling, and disposal of reagents, maintaining compliance with safety and environmental regulations.
• Maintained laboratory cleanliness, ensured availability of calibrated instruments, and verified reagent validity for routine use.
• Entered and reviewed analytical data in Laboratory Information Management Systems (LIMS) ensuring traceability and data integrity.
• Calibration of analytical instruments like HPLC, UPLC, GC and Dissolution apparatus.

Master of Health information Technology in Health Information Technology – University of Maryland Baltimore county

Bachelor of Technology in Biotechnology – Vignan University