Quality Engineer (Manufacturing)

WillHire; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen erfahrenen Qualitätsingenieur, der in einem GMP-Umfeld tätig ist. In dieser Rolle unterstützen Sie die QA-Operationen und stellen sicher, dass die neuen Radioligand-Therapien den höchsten Qualitätsstandards entsprechen. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass alle regulatorischen Anforderungen erfüllt werden. Diese spannende Gelegenheit bietet die Möglichkeit, Teil eines Teams zu sein, das sich der Verbesserung der Patientenversorgung widmet und dabei innovative Lösungen in der Biopharmazeutik entwickelt. Wenn Sie eine Leidenschaft für Qualität und Compliance haben, ist dies die perfekte Chance für Sie.

Benefits

Gesundheitsversorgung

Zahnversicherung

Sehversicherung

401k

Qualifications

• Bachelor-Abschluss in Lebenswissenschaften oder Chemie erforderlich.
• Mindestens 2 Jahre Erfahrung in GxP-Biopharma-Betrieb.

Responsibilities

• QA-Kontaktpunkt und Fachexperte für Design und Validierung.
• Unterstützung bei der Erstellung von Dokumentationen für regulatorische Einreichungen.

Skills

Qualitätskontrolle

GxP Biopharma-Erfahrung

cGMP-Anforderungen

FDA-Vorschriften

Kommunikationsfähigkeiten

Education

Bachelor in Lebenswissenschaften oder Chemie

3-5 Jahre Erfahrung in der pharmazeutischen Industrie

Job description

~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...
Quality Engineer

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced Quality Engineer with previous experience in a GMP pharmaceutical manufacturing environment to help us reach our ambitious goals.

As the Quality Engineer, you will be responsible for providing support to the QA Operations organization for the review and approval of technical records. Your focus will be to support the design construction, commissioning, qualification and validation of the new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis ensuring compliance to quality objectives and regulatory requirements.

Key Responsibilities:
• Act as QA contact point and subject matter expert for the design, construction, commissioning, qualification and validation activities for manufacturing and QC areas.
• In collaboration with the Site’s Manufacturing Science and Technology (MS&T) department reviews and approves the establishment, review and approval of the expansion project qualification and validation master plans.
• Supports the creation and review of source documentation intended to be used for regulatory submission. Supports the preparation and execution of pre-approval inspection by FDA or any other heath authority.
• Under the guidance of the Quality Assurance Engineer Lead, perform triaging and initiation of events (Deviation, Action, CAPA, etc.). Expected to work with and partner with cross functional departments during triaging.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
• Actively engage in process improvement and Right First-Time initiatives. Ensures adherence of appropriate regulations and Novartis quality standards.
• Write and/or review of Standard Operating Procedures (SOPs), as needed.
• Other related duties as assigned.

Essential Requirements:
• Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance experience will be considered
• 2+ years of experience in a GxP Biopharmaceutical manufacturing operations
• 1+ years of experience in a quality assurance role
• Open and clear collaboration and communication skills
• QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
• Proven track record and practical experience with cGMP requirements
• Knowledge of FDA regulations and experience in US regulatory agency inspections.

Location: Indianapolis, IN (Onsite)
Pay Rate: $29.77 - $37.16/hour based on experience and qualifications (W2 Only)
Contract: 12 months
Health, dental, vision, 401k

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [e-mail].