Quality Assurance Specialist

Responsibilities

• Creation, implementation and support of a comprehensive QMS (Quality Management System)
• Participate in the qualification of key suppliers, including executing internal and external audits and assessments
• Creation and implementation of processes which support manufacturing of active drug substance, such as issuance of batch records and test records, raw material release, batch record review, and finished drug product release
• And management of site training and development programs, including GMP and GDP training
• Support of critical manufacturing investigations, including out of specification results and deviations in the manufacturing process
• Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Commission, Food and Drug Administration, European Union, etc.)
• Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site

Requirements

• Bachelor's degree in the life sciences or other technical field is required
• 5+ years working in a quality control or quality assurance position supporting GMP manufacturing is required
• Experience working in PET drug or radiopharmaceutical manufacturing under 21 CFR 210, 211 and/or 212 current Good Manufacturing Practices (cGMPs) is strongly preferred
• Strong understanding of GMP and radiation safety principles is preferred
• Detail-oriented mindset with excellent organizational and record-keeping skills
• Effective communication and teamwork abilities, with a focus on collaborative problem solving
• Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy
• Flexibility to work in shifts or outside of normal business hours to handle time-sensitive processes
• Strong commitment to safety, ethical conduct and compliance with regulations

Benefits

We offer a competitive salary, a comprehensive package of benefits, and advancement opportunity.

About the Role

At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day.