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Genezen · 2 months ago

Quality Control Lab Analyst II

Indianapolis, IN

Full-time

Onsite

Entry, Mid Level

2+ years exp

Genezen is a rapidly growing company in the field of gene therapy, dedicated to meeting the needs of clients through process development and the production of GMP viral vectors. The QC Analyst II is responsible for executing complex laboratory functions related to viral vector production and analytics, ensuring compliance with cGMP guidelines while mentoring junior analysts.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

Independently manage ordering, inventory control, and lifecycle tracking of lab reagents and critical materials to ensure uninterrupted testing operations

Coordinate and oversee sample organization, prioritization, and testing workflows with minimal supervision

Lead sample shipping and receiving processes for internal and outsourced testing, ensuring accurate chain of custody and compliance with applicable regulations

Execute complex hands-on laboratory procedures related to viral vector production and analytical characterization, including troubleshooting and optimization of methods

Review and ensure accurate, compliant cGMP documentation of laboratory activities; support deviation investigations and CAPA implementation as needed

Perform advanced laboratory and equipment maintenance, and coordinate with internal teams or vendors for calibration, qualification, and repair activities

Serve as a technical trainer and mentor to new staff and junior analysts, supporting their development and adherence to best practices

Ensure compliance with all established policies, SOPs, and cGMP requirements while identifying opportunities for procedural improvements

Collaborate with Quality Assurance and leadership in the development, review, and revision of SOPs, protocols, and related documentation

Responsible for attending client project meetings, tracking related QC activities and ensuring timely execution of project milestones

Actively support and contribute to method qualification, validation, and transfer activities, including drafting protocols, analyzing data, and preparing summary reports