QC Analyst III-Cell Culture (Sunday-Thursday)

Role Summary

QC Analyst III-Cell Culture (Sunday-Thursday) performs advanced quality activities in support of product production and releases with minimal supervision. This position interfaces with multiple internal departments and external entities to ensure regulatory compliance through testing, trending, and reporting results. Shift is Sunday–Thursday with initial training Mon-Fri for ~6 months.

Responsibilities

• Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing.
• Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and assay development/optimization.
• Interact and coordinate with Manufacturing and QA Operations daily.
• Coordinate test sample receipt and scheduling.
• Execute assigned tasks with minimal supervision.
• Donate tissue receipt and transfer.
• Identify and report areas for process improvement.
• Generate and execute feasibility/validation protocols.
• Generate trend reports as they relate to quality testing.
• Work closely with team members to ensure timely release of materials.
• Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
• Revise/Create SOPs.

Qualifications

• Bachelor‚Äôs degree in Biology or related field, with 5-7 years of related experience.
• Cell Culture experience required. Experience in GMP regulated environment preferred.
• Flow Cytometry [FACS CANTO II] experience preferred.

Skills

• Strong technical and scientific aptitude in cell culture and related assays.
• Ability to work cross-functionally and coordinate with multiple teams.
• Proficiency in creating and interpreting trend, deviation, and validation reports.
• Strong documentation and SOP revision capabilities.

Education

• Bachelor‚Äôs degree in Biology or related field.

Additional Requirements

• Physical requirements related to repetitive hand movement and occasional gowning for QC activities.