QC Analyst

Key Responsibilities

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility.
• Reviewing assays.
• Training others.
• Writing-Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects - such as method transfers, new instruments, method qualifications.
• Using Microsoft Suites (Word, Excel, PowerPoint).
• Using Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.

Requirements

• Bachelors in Microbiology, Biochemistry, or related field.
• 5-10 years of relevant QC Micro experience in GMP.

Qualifications

Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
Acts as an area SME providing technical support within the department and throughout the facility.