Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. 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. We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

• Creation, implementation and support of a comprehensive QMS (quality management system).
• Creation of a supplier management program, including evaluation, selection and approval of site vendors.
• Creation and support of processes to support manufacturing, such as issuance of batch records and test records, raw material release, batch record review, and finished drug product release.
• Creation 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.
• Creation and management of internal and external auditing programs for the site.
• 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 Agency, Food and Drug Administration, etc).
• Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.

Requirements

Education and Skills:

• 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.
• Operational 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 cGMP requirements and radiation safety practices 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 and handle time-sensitive processes.
• Strong commitment to safety, ethical conduct, and compliance with regulations.

Benefits

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

As an Equal Opportunity Employer, we are committed to a diverse workforce.