About the Job

We’re hiring a Quality Assurance Specialist focused on Process Improvement to join our growing Quality team. This Specialist 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 aspects of process improvement 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 areas of Quality, including CAPAs, Deviations, Event Reports and Complaints. You’ll play a critical role in ensuring that we maintain our high Quality standards across multiple systems.

This role reports directly to the Quality Assurance Supervisor, Process Improvement.

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 effectively organize and manage multiple responsibilities simultaneously
• Ability to meet short- and long-term deadlines
• Ability to complete tasks and projects with little oversight
• Able to effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
• High level of professionalism and good judgment
• 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

• Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
• Proven ability to work well in a cross-functional team environment
• Understanding of 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

• Own 2+ aspects of the specialty and/or projects relating to the specialty, which may include investigations, non-conformances, document control, complaint handling, procedure review and approval, nonconforming product, risk assessment, change control, OOS, etc.
• Investigate different areas of Quality which include CAPAs, Deviations, Event Reports, and Complaints
• Provide Root Cause Analysis support
• Define risk and mitigation, which may include failure mode and effects analysis
• Provide corrective/preventive actions
• Provide QA support to Production, Manufacturing, and Quality Control as needed
• 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
• Shadowing Ossium’s operational processes
• Providing Quality Assurance support for Event Reports, CAPAs, Deviations, and Complaints
• Identifying areas of improvement in the quality processes

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements