Novartis · 4 weeks ago
Quality Assurance(QA) Operations Specialist
Indianapolis
Full-time
Onsite
Entry, Mid Level
$81K/yr - $151K/yr
2+ years expNovartis is pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. The QA Operations Specialist is responsible for managing quality aspects and projects to ensure compliance with GxP and Novartis Quality Management Systems at the Indianapolis manufacturing site.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 3-5 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
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
QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis 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
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-23
Company data provided by crunchbase