Novartis Pharma Schweiz · 3 weeks ago
Quality Assurance(QA) Operations Specialist
Indianapolis, IN
Full-time
Onsite
Entry, Mid Level
$81K/yr - $151K/yr
2+ years expNovartis Pharma Schweiz is pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. The QA Operations Specialist manages quality aspects and projects to ensure compliance with GxP standards at the Indianapolis manufacturing site.
Health CarePharmaceutical
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, 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 Pharma Schweiz
At Novartis, our mission is to discover new ways to improve and extend people's lives.
Founded in 1997Tokyo, Tokyo, JPN
201-500 employees
H1B Sponsorship
Novartis Pharma Schweiz 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 StageRecent News
The Express Tribune
2025-11-10
FiercePharma
2025-10-31
Company data provided by crunchbase