Quality Assurance Specialist - PET Manufacturing

Quality Assurance Specialist - PET Manufacturing

Job Summary

Jubilant Radiopharma, a leader in radiopharmaceutical manufacturing and radiopharmacy operations, is seeking a dedicated Quality Assurance Specialist to support our Positron Emission Tomography (PET) manufacturing operations. The QA Specialist will ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to deliver safe and effective radiopharmaceutical products. This role requires a detail-oriented professional with a strong background in quality assurance within pharmaceutical or radiopharmaceutical manufacturing environments.

Key Responsibilities

• Quality Oversight for PET Manufacturing: Conduct comprehensive quality assurance reviews of manufacturing processes, batch records, and documentation across Jubilant Radiopharma's PET manufacturing operations to ensure compliance with GMP, FDA (e.g., 21 CFR Part 211, 212), and other regulatory standards.
• Decentralized PET Network Oversight: Provide quality assurance oversight for Jubilant Radiopharma's decentralized PET manufacturing network, ensuring consistent quality standards across multiple sites. Collaborate with regional manufacturing facilities to align processes, documentation, and compliance with corporate and regulatory expectations.
• Auditing and Inspections: Plan and execute internal audits of PET manufacturing processes at both local and decentralized network sites. Prepare for and support external regulatory inspections, ensuring adherence to Standard Operating Procedures (SOPs) and quality standards across all locations.
• Deviation and CAPA Management: Lead investigations into deviations, non-conformances, and quality incidents occurring within the PET manufacturing network. Develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence, ensuring consistency across decentralized sites.
• Document Control and Standardization: Review, approve, and maintain quality-related documentation, including SOPs, validation protocols, batch records, and network-specific procedures. Ensure standardized documentation practices are implemented across the decentralized PET network to maintain compliance and traceability.

• Change Control Management: Evaluate and manage change control processes for manufacturing processes, equipment, or systems, ensuring that changes across the decentralized PET network maintain product quality and regulatory compliance. Coordinate with network sites to assess change impacts and implement controls.

• Training and Compliance Support: Develop and deliver training programs for manufacturing personnel on quality procedures, GMP requirements, and network-specific protocols. Foster a culture of quality and compliance across all PET manufacturing sites by providing ongoing support and guidance.
• Risk Assessment and Mitigation: Conduct risk assessments to identify potential quality issues in PET manufacturing processes, including those specific to decentralized operations. Propose and implement mitigation strategies to ensure product safety and regulatory adherence across the network.
• Collaboration Across Teams and Sites: Work closely with cross-functional teams, including manufacturing, quality control, and regulatory affairs, both locally and within the decentralized PET network, to support product release, process improvements, and network-wide quality initiatives. Facilitate communication to ensure alignment on quality objectives.
• Validation and Qualification Support: Oversee and support validation and qualification activities for manufacturing equipment, processes, and systems, ensuring compliance with regulatory requirements. Coordinate validation efforts across decentralized sites to maintain consistency and quality.
• Quality Metrics and Reporting: Monitor and report on key quality metrics for PET manufacturing operations, including network-wide performance. Identify trends and recommend improvements to enhance quality and efficiency across all sites.

Qualifications

• Education: Bachelor's degree in chemistry, Biology, Pharmacy, or a related scientific field.

• Experience: Minimum of 3-5 years of quality assurance experience in pharmaceutical, radiopharmaceutical, or a related GMP-regulated manufacturing environment.

• Knowledge: Strong understanding of GMP, FDA regulations (e.g., 21 CFR Part 211, 212), and ICH guidelines. Familiarity with PET manufacturing processes and decentralized manufacturing networks is a plus.

• Skills:
  • Excellent attention to detail and problem-solving skills.
  • Strong written and verbal communication skills for effective documentation and collaboration across multiple sites.
  • Proficiency in quality management systems (QMS) and related software.
  • Ability to manage multiple priorities in a fast-paced, multi-site environment.

• Certifications: Quality-related certifications (e.g., ASQ Certified Quality Auditor) are desirable but not required.

Preferred Qualifications

• Experience with radiopharmaceuticals or PET manufacturing processes.
• Knowledge of aseptic manufacturing and sterile product requirements.
• Familiarity with validation and qualification processes for manufacturing equipment and systems.
• Experience working in or managing quality assurance for decentralized or multi-site manufacturing operations.

Why Join Jubilant Radiopharma?

At Jubilant Radiopharma, we are committed to advancing nuclear medicine through innovative radiopharmaceutical solutions. As a QA Specialist, you will play a critical role in ensuring the safety and quality of our products, making a meaningful impact on patient lives. We offer a collaborative work environment, competitive compensation, and opportunities for professional growth.

At Jubilant Radiopharma, we champion an inclusive workplace that treasures diverse perspectives, experiences, and backgrounds. We are committed to building a diverse yet inclusive workplace that is representative of the marketplace and the communities in which the Company operates.

Jubilant Radiopharma is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law.

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information.

We look forward to speaking with you about this exciting new career opportunity