Quality Assurance Batch Release Specialist II

About This Role

This role involves providing quality assurance for batch release activities within a CAR-T facility, supporting clinical and commercial efforts for material release for human use. The specialist will ensure compliance with cGMP regulations and contribute to timely product disposition.

Responsibilities

• Responsible for disposition of final drug product
• Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP)
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives
• Author and review release documentation
• Collaborate with functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results for timely release of final product batches
• Perform duties/tasks under minimal supervision according to standard operating and manufacturing procedures
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance
• Ensure readiness of records for regulatory inspections and internal audits

Requirements

• Minimum of a Bachelor’s degree in Science, Engineering or equivalent technical field
• Minimum of 2 years of relevant experience within Manufacturing, Quality Assurance or Batch Release in either the pharmaceutical or biotech industries
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines
• Highly organized, with proven attention to detail and ability to follow procedures with minimal supervision
• Proficient verbal communication skills, with the ability to effectively summarize and present results
• Ability and flexibility to work 10-hr shifts between the operational hours of 8am-7pm, and weekends or other shifts

Qualifications

• Bachelor’s degree in Science, Engineering or equivalent technical field
• Minimum of 2 years of relevant experience within Manufacturing, Quality Assurance or Batch Release in either the pharmaceutical or biotech industries

Nice to Have

• Knowledge of cGMP/GTP regulations and FDA
• Strong social skills, willingness to take initiative, and capability of working in a collaborative team environment

Skills

* Required skills

Benefits