Quality Control Lab Analyst II

Genezen • Indianapolis, IN

70d

About The Position

The QC Analyst II is responsible for performing and supporting a broad range of advanced laboratory functions related to viral vector production and analytics in accordance with cGMP testing guidelines. In this role, the analyst independently executes complex molecular biology assays, aseptic cell culture techniques, and analytical testing with minimal supervision. The position also includes responsibilities for sample and materials management, solution/media preparation, and general lab maintenance, with an increased emphasis on method troubleshooting, data review, and deviation documentation. The QC Analyst II contributes to method qualification, equipment calibration and validation, and supports continuous improvement efforts. This role serves as a technical resource for junior analysts, helping to uphold quality standards and drive operational excellence within the Quality Control team.

Requirements

• Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
• 2+ years of relevant industry experience in QC, R&D, product development, or operations
• Excellent computer, verbal, and written communication skills
• Experience with laboratory techniques including cell culture, cell-based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis

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

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees