QC Analyst 1

Primary Responsibilities

• Perform routine testing and sampling (EM, utilities, raw materials, inprocess, finished goods) in accordance with SOPs and cGMP requirements
• Accurately document, review, and report data in compliance with GDP and ALCOA+ principles
• Execute assigned testing and support activities within defined timelines
• Support laboratory operations including housekeeping, inventory management, and basic equipment care
• Identify and escalate deviations, atypical results, or compliance concerns

Secondary Responsibilities

• Assist with sample coordination and shipment to external laboratories
• Support SOP revisions and documentation updates
• Participate in training to build proficiency across assays
• Provide support for validation or innovation projects as assigned

Laboratory Time Expectation

~80-90% laboratory-based work

Key Competencies

• Foundational laboratory skills and aseptic technique
• Strong attention to detail and data integrity awareness
• Basic prioritization and time management (with guidance)
• Clear written and verbal communication
• Ability to follow procedures and learn new techniques