About the Job

We're hiring a Quality Assurance Associate II as part of our growing Quality team. This Associate will be responsible for assessing and reviewing the quality systems used to produce cell therapy products in accordance with applicable procedures, standards, and regulations. The individual should be capable of providing guidance on established Quality Systems and be capable of owning multiple Quality Systems used to support the business.

In this role, you'll collaborate with and provide Quality Assurance support to our Clinical Production, Clinical Manufacturing, Quality Control, and Operations teams. You'll be responsible for investigations into multiple different areas of Quality, including CAPAs, Deviations, and Event Reports. You'll play a critical role in ensuring that we maintain our high Quality standards across multiple systems.

This role reports directly to the Senior Quality Associate.

Required Qualifications

• Bachelor or Associate degree in Life Sciences or Chemistry and 2+ years of experience in Quality
• Excellent written and oral communication skills, able to communicate across teams and departments
• Ability to complete tasks and projects with little oversight
• Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
• Strong computer skills, including Microsoft Office
• Capability to operate with a high level of organization, professionalism, and excellent time management in a dynamic startup environment
• This position is based full-time in our Indianapolis office

Preferred Qualifications

• Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, AATB Standards, and other GMP requirements
• Familiarity with and previous experience working with Master Control, preferably in the Process module

Key Responsibilities

• Manage 3+ Quality Systems which may include investigations, non-conformances, document control, training, procedure review and approval, nonconforming product, final product disposition, review of completed logs and forms, risk assessment, change control, OOS, etc
• Investigate CAPAs, Deviations, and Event Reports
• Provide Root Cause Analysis support
• Define risk and mitigation, which may include failure mode and effects analysis
• Provide corrective/preventive actions
• Collaborate with Operations to ensure processes are maintained and executed in accordance with established procedures and applicable regulations
• Report on Quality Systems performance and drive continuous improvement initiatives; identify and propose best practices
• Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends
• Provide Quality Assurance guidance and collaborate with Operations in resolving quality, documentation, and training issues
• Design, review, and approve quality procedures and monitor compliance to procedures

In your first six months some projects you'll work on include:

• Diving deep into our Quality Management System Master Control to learn the modules and understand the workflow
• Completion of internal audits in all areas of operations
• Provide Quality Assurance support for Event Reports, CAPA's and Deviations

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Generous paid time off + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements