Quality Assurance Specialist - CQV presso Isotopia USA

Description

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 - CQV 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 team, dedicated to our mission to deliver on our covenant with our customers.

The Quality Assurance Specialist – CQV is responsible for providing Quality oversight and compliance support for Commissioning, Qualification, and Validation (CQV) activities in a GMP radiopharmaceutical manufacturing environment. This role ensures that facilities, utilities, equipment, computerized systems, and processes are commissioned, qualified, and validated in accordance with FDA 21 CFR Parts 210/211, EU GMP (EudraLex Volume 4), ICH guidelines, and site Quality Management System (QMS) requirements.

The QA Specialist – CQV partners closely with Engineering, Manufacturing, Validation, and Quality teams to ensure lifecycle-based validation practices are applied, risks are appropriately assessed, and systems are fit for intended use prior to GMP operations and product release.

Responsibilities:

• Provide Quality Assurance oversight and review for commissioning, qualification, and validation activities, including facilities, utilities, process equipment, laboratory equipment, and computerized systems
• Review and approve CQV lifecycle documentation, including validation plans, risk assessments, protocols (IQ/OQ/PQ), reports, traceability matrices, and deviation summaries
• Verify that systems are qualified for intended use prior to GMP manufacturing and batch release
• Ensure CQV activities comply with FDA 21 CFR Parts 210/211, EU GMP (including Annex 11 where applicable), and internal Quality standards
• Support alignment of CQV practices with Annex 1 requirements for sterile/radiopharmaceutical manufacturing, where applicable
• Ensure data integrity principles (ALCOA+) are applied throughout CQV documentation and execution
• Support change control activities related to validated systems, including impact assessments on validated state
• Participate in deviation investigations, OOS/OOT investigations, and CAPAs related to CQV activities or validated systems
• Ensure CQV documentation is properly controlled within the document management system
• Support periodic review and requalification activities to maintain the validated state
• Partner with Engineering, Validation, IT, Manufacturing, QC, and Radiation Safety to ensure quality expectations are clearly defined and met
• Provide QA guidance during system design, installation, and startup phases to ensure compliance is built in from the outset
• Support vendor qualification and review of supplier validation documentation where applicable
• Identify opportunities to improve CQV processes, templates, and execution efficiency while maintaining compliance
• Support development and revision of SOPs, templates, and training related to CQV and validation lifecycle management
• Contribute to inspection readiness and continuous GMP compliance initiatives
• Execution of batch release
• Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site

Requirements

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical discipline required
• 4–7 years of experience in a GMP-regulated pharmaceutical, radiopharmaceutical, biotechnology, or API manufacturing environment
• Minimum 3–5 years of hands-on experience supporting or overseeing Commissioning, Qualification, and Validation (CQV) activities
• Demonstrated experience providing Quality Assurance oversight of CQV documentation and execution, including review and approval of IQ/OQ/PQ protocols and reports
• Working knowledge of FDA 21 CFR Parts 210 and 211, EU GMP (EudraLex Volume 4), and ICH Q8/Q9/Q10
• Experience supporting regulatory inspections and audits (FDA, EMA, HPRA, or equivalent), including direct interaction with inspectors on CQV-related topics preferred
• Practical experience with risk-based validation approaches, including FMEA or similar risk assessment tools
• Experience with change control, deviations, and CAPA management as related to validated systems
• Familiarity with Annex 1 requirements and contamination control principles for sterile or radiopharmaceutical manufacturing preferred
• Experience with computerized systems validation (CSV) and Annex 11 compliance preferred

Benefits

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

As an equal opportunity employer, we are committed to a diverse workforce.