QC Analyst 3

Summary: The Quality Control Analyst will support the Quality Control department and production by contributing to technical transfer activities. The role requires experience in a pharmaceutical GMP environment, laboratory systems, data analysis, software validation, and Data Integrity. Roles & Responsibilities: Support Quality Control and production activities related to technical transfers. Perform assigned QC tasks according to GMP procedures and company policies. Work with SoftMax Pro, Empower, and SoloVPE. Support method and software validation, including writing GMP procedures, validation documents, and executing test scripts. Act as an SME for at least one software system. Perform basic technical troubleshooting and root-cause analysis for software issues. Apply Data Integrity principles to all work. Work with laboratory computer systems and GMP quality systems such as TrackWise and LIMS. Use Microsoft Word, Excel, and PowerPoint. Analyze and interpret data accurately. Communicate effectively with cross-functional teams. Complete assignments accurately and on time. Follow all GMP, quality, training, and company requirements. Maintain reliable attendance and work the complete assigned shift. Mandatory Experience: 3-5 years of experience in a pharmaceutical GMP Quality Control environment. Hands-on experience with SoftMax Pro, Empower, and/or SoloVPE. Experience with method and/or software validation. Experience writing GMP procedures and validation documents. Experience executing validation test scripts. Experience with laboratory computer systems. Strong understanding and application of Data Integrity principles. Experience with technical troubleshooting and root-cause analysis for software issues. Experience using Microsoft Word, Excel, and PowerPoint. Strong written and verbal communication skills. Ability to interpret data and follow GMP procedures accurately. Preferred: Experience with TrackWise and/or LIMS and experience acting as an SME for a laboratory software system. Education: Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific/technical field. #J-18808-Ljbffr Katalyst-Healthcares-