Quality Assurance Operations Specialist

Role Summary

Quality Assurance Operations Specialist responsible for managing quality aspects and projects within area of responsibility, ensuring GxP conformity, and supporting compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. On-site in Indianapolis, IN with specified shift and rotating schedule.

Responsibilities

• Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure practice fully adheres to cGMP, including data integrity. Escalate incidents to management promptly.
• Perform live review of manufacturing batch records in preparation for batch release and escalate discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition.
• Review, approve and support procedures and production/testing records; assist in training site associates.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Support FDA/Regulatory interactions for 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

• Required: Bachelor‚Äôs Degree, preferably in Life Sciences, chemistry, or related field; or 3-5 years in pharma quality assurance if no degree.
• Required: 2+ years of experience in a GxP Biopharmaceutical manufacturing operations
• Required: 1+ years of experience in a quality assurance role
• Cross-functional collaboration
• QA and QC experience in biotech/pharmaceutical industry with environmental monitoring and cleanliness zones is desirable
• Proven track record with cGMP requirements
• Knowledge of FDA and EU regulations and experience with US and international regulatory inspections

Skills

• Quality oversight and data integrity
• Batch record review and disposition
• Procedures and record review/approval
• Aseptic techniques and sterile manufacturing
• Regulatory interactions and inspections
• Cross-functional collaboration

Education

• Bachelors' Degree (Life Sciences, Chemistry, or related) or equivalent pharma QA experience

Additional Requirements

• Location: Indianapolis, Indiana (on-site)
• Shift: Thursday-Sunday 1 PM through 1 AM; rotating 4-day/3-day weeks