QA Operations Supervisor
Novartis
3 months ago
On-site
Indianapolis, IN
$89,600 - $166,400 USD yearly
Operations
Key Responsibilities:
- Provide direct supervision of QA Operations Specialists and QA Batch Release Specialists, ensuring alignment with site quality objectives.
- Coordinate daily activities, prioritize workload, and ensure timely completion of QA tasks across both functions.
- Serve as primary point of contact for quality-related issues during assigned shifts; ensure timely escalation and resolution.
- Provide shopfloor quality oversight of production, QC, and supply chain activities; verify adherence to cGMP, aseptic techniques, and data integrity standards.
- Oversee live review of manufacturing batch records and documentation to support timely, compliant batch release.
- Confirm compliance of site personnel with sterile manufacturing regulations and internal procedures.
- Support release of all manufactured, packaged, and tested products.
- Support controlled issuance of batch records in preparation for manufacturing.
- Review manufacturing batch records in preparation for batch release; escalate discrepancies immediately.
- Support metric tracking of documentation and release data to enable continuous improvement.
- Provide quality oversight for Deviation, Change Control, and CAPA management.
- Maintain batch documentation library (record check-in, check-out, follow-up, distribution).
- Provide shopfloor quality oversight across production, quality control, and supply chain to ensure full cGMP (including data integrity) compliance and timely incident escalation.
Essential Qualifications:
- Bachelor’s degree (preferred: Life Sciences, chemistry, or related). Equivalent: 5 years in pharma quality assurance and batch release.
- 3+ years’ experience in GxP biopharmaceutical manufacturing operations.
- 2+ years’ experience in a quality assurance role.
- Cross-functional QA/QC collaboration experience in biotech pharmaceutical manufacturing (environmental monitoring & cleanliness zones desired).
- Practical, proven experience with cGMP.
- Knowledge of FDA and EU regulations; experience with US and international regulatory inspections.
Benefits:
- Performance-based cash incentive; annual equity award eligibility (depending on level).
- Comprehensive US-based benefits: health, life, disability; 401(k) with company contribution and match; time-off (vacation, personal days, holidays, other leaves).
Application instructions:
- Not specified in the provided text.
- Provide direct supervision of QA Operations Specialists and QA Batch Release Specialists, ensuring alignment with site quality objectives.
- Coordinate daily activities, prioritize workload, and ensure timely completion of QA tasks across both functions.
- Serve as primary point of contact for quality-related issues during assigned shifts; ensure timely escalation and resolution.
- Provide shopfloor quality oversight of production, QC, and supply chain activities; verify adherence to cGMP, aseptic techniques, and data integrity standards.
- Oversee live review of manufacturing batch records and documentation to support timely, compliant batch release.
- Confirm compliance of site personnel with sterile manufacturing regulations and internal procedures.
- Support release of all manufactured, packaged, and tested products.
- Support controlled issuance of batch records in preparation for manufacturing.
- Review manufacturing batch records in preparation for batch release; escalate discrepancies immediately.
- Support metric tracking of documentation and release data to enable continuous improvement.
- Provide quality oversight for Deviation, Change Control, and CAPA management.
- Maintain batch documentation library (record check-in, check-out, follow-up, distribution).
- Provide shopfloor quality oversight across production, quality control, and supply chain to ensure full cGMP (including data integrity) compliance and timely incident escalation.
Essential Qualifications:
- Bachelor’s degree (preferred: Life Sciences, chemistry, or related). Equivalent: 5 years in pharma quality assurance and batch release.
- 3+ years’ experience in GxP biopharmaceutical manufacturing operations.
- 2+ years’ experience in a quality assurance role.
- Cross-functional QA/QC collaboration experience in biotech pharmaceutical manufacturing (environmental monitoring & cleanliness zones desired).
- Practical, proven experience with cGMP.
- Knowledge of FDA and EU regulations; experience with US and international regulatory inspections.
Benefits:
- Performance-based cash incentive; annual equity award eligibility (depending on level).
- Comprehensive US-based benefits: health, life, disability; 401(k) with company contribution and match; time-off (vacation, personal days, holidays, other leaves).
Application instructions:
- Not specified in the provided text.