QC Specialist II

Job Responsibilities:

• echnical Transfer Support: Collaborate in the completion of technical transfer activities, ensuring a smooth transition of processes or methods between departments.
• Sample Testing: Run test samples for in-process, lot release, and stability studies. Conduct tests for investigations, method validations, and transfers.
• Data Analysis: Review assay results and interpret data. Identify deviations from accepted practices and apply corrective actions where necessary.
• Quality Records: Prepare and maintain quality records, including deviations, CAPAs, change controls, and test methods.
• Training: Train other team members and provide technical guidance on QC practices and software tools.
• Software Validation & Usage: Utilize laboratory computer systems (e.g., TrackWise, LIMS) and software such as SoftmaxPro, Empower, and SoloVPE. Write GMP procedures and validation documents, execute test scripts.
• Cross-Functional Collaboration: Communicate with cross-functional teams to understand and prioritize testing needs.
• Project Management: Lead projects related to method transfers, new instruments, and qualification processes.
• Problem Solving: Perform root-cause analysis on software errors and operational issues.
• Data Integrity & Compliance: Ensure compliance with Data Integrity policies and Lonza DI procedures in all activities.

Skills:

• Testing & Analysis: Experience in running in-process, lot release, and stability test samples, including technical aspects of method validation and investigation.
• GMP Systems: Familiarity with GMP quality systems such as TrackWise, LIMS, and validation protocols.
• Software Skills: Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint), and laboratory software like SoftmaxPro, Empower, and SoloVPE.
• Root Cause Analysis: Strong skills in identifying, analyzing, and resolving issues related to testing processes, data, and software systems.
• Documentation: Ability to write and manage quality records, including deviations, CAPAs, change controls, and test methods.
• Data Integrity: Knowledge and application of Data Integrity principles in all aspects of QC work.
• Regulatory Knowledge: Familiarity with pharmaceutical GMP regulations and industry standards.
• Communication: Strong verbal and written communication skills, including the ability to explain complex data and technical concepts to both technical and non-technical audiences.
• Technical Transfer & Validation: Experience or understanding of method transfer projects, software validation, and instrument qualifications.

Education/Experience:

• Education: Associate’s Degree in Microbiology, Biochemistry, or a related science field.
• Experience: Prior experience in a GMP-compliant environment within the pharmaceutical industry, with a focus on quality control testing, method validation, and cross-functional collaboration.