Job Description Summary
The QC Analyst I is an entry-level role responsible for executing routine laboratory testing and sampling in support of quality control operations. This role focuses on building foundational technical skills while ensuring all work is performed in compliance with cGMPs and standard procedures. The Analyst I primarily supports day-to-day laboratory activities and develops proficiency across assigned methods and systems.
Job Description Roles and ResponsibilitiesPrimary Responsibilities- Perform routine testing and sampling (EM, utilities, raw materials, in-process, 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.
- Majority of time spent executing routine testing and sampling activities.
- Limited non-lab responsibilities, primarily focused on documentation and training.
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.