QA Operations Specialist

Job Description Summary

#LI-Onsite
This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 experienced Quality Control professionals to help us reach our ambitious goals.
Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems.  

Job Description

Major accountabilities:

• Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition of the product.
• Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
• Other related duties as assigned.

Shift: This role will be Wednesday - Sunday, 6:00am - 4PM. This position may involve mandatory overtime as needed.

Essential Requirements:

• Bachelor's Degree, preferably in Life Sciences, chemistry or related relevant degree.
• 2+ years of experience in a GxP Biopharmaceutical manufacturing operations
• 1+ years of experience in a quality assurance role
• Collaborating across boundaries
• Functional Breadth
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$88,000.00 - $132,000.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence