Quality Assurance(QA) Operations Specialist

Role Summary

QA Operations Specialist manages quality aspects and projects within the area of responsibility and ensures overall GxP conformity and compliance with the Novartis Quality Management Systems at the Indianapolis manufacturing site. The role supports safe, reliable, and compliant production of Radioligand Therapies in a on-site facility, with night shift (weekends).

Responsibilities

• 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.

Qualifications

• Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 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
• Cross functional collaboration
• 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 and EU regulations and experience in US and international regulatory agency inspections.

Education

• Bachelors' Degree in Life Sciences, Chemistry, or related field (or equivalent experience as listed above).