Novartis ACC · 3 weeks ago
QA Operations Supervisor
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$90K/yr - $166K/yr
5+ years expNovartis ACC is pioneering the future of treatment through the fusion of nuclear medicine and precision oncology, and they are seeking a QA Operations Supervisor. This role provides hands-on support for quality oversight and batch release activities while supervising QA Operations and Batch Release Specialists.
Pharmaceuticals
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 the primary point of contact for quality-related issues during assigned shifts, ensuring timely escalation and resolution
Ensure shopfloor quality oversight of production, QC, and supply chain activities, verifying adherence to cGMP, aseptic techniques, and data integrity standards
Oversee live review of manufacturing batch records and documentation to support timely and compliant batch release
Confirm compliance of site personnel with sterile manufacturing regulations and internal procedures
Support the release of all manufactured, packaged and tested
Support the Controlled issuance of batch records in preparation for manufacturing
Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately
Support metric tracking of documentation and release data to ensure continuous improvement
Support all QA operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity
Provide Quality Oversight on Deviation, Change Control, and CAPA management
Maintain batch documentation library (record check-in, check-out, follow-up, and distribution)
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
Qualification
Required
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 and batch release experience will be considered
3+ years of experience in GxP Biopharmaceutical manufacturing operations
2+ years of experience in a quality assurance role
Proven track record and practical experience with cGMP requirements
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections
Preferred
Cross functional collaboration QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A variety of other benefits
A generous time‑off package including vacation, personal days, holidays and other leaves
Company
Novartis ACC
Novartis está reimaginando la medicina con el fin de mejorar y prolongar la vida de las personas.
201-500 employees
H1B Sponsorship
Novartis ACC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (11)
Funding
Current Stage
Growth StageCompany data provided by crunchbase