Senior QC Analyst (2nd Shift) – In-Process

Responsibilities

• In-process, characterization, stability, and/or release testing as assigned.
• Execution of method transfer, method qualification, and/or method validation testing performed under protocol.
• Solution preparation.
• Organizes and processes samples according to GxP standards.
• Independently analyzes and collates data to draw conclusions.
• Enters data into control charts and LIMS, if applicable.
• Supports lab investigation and deviation reports.
• Supports implementation of Corrective and Preventive Actions.
• Revise SOPs and technical documents.
• Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data.
• Tracks department metrics upon request; actively engages in improvement of department metrics.
• Partakes in continuous improvement projects or leading simple improvement projects.
• Ensures state of safety and regulatory audit readiness at all times.
• Maintains work to current Good Manufacturing Practices (cGMP).
• Ensures Trainer qualification status to expand team matrix.
• Laboratory support – ensures areas are neat, clean, organized, and equipment is functioning.
• Participates in data review activities.

Qualifications

• Relevant degree and 4-8 years’ biopharmaceutical industry experience, preferably in protein analytics.

Pay

$63,000-$86,900 KBI

Schedule

2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday