~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...
QA Operations Specialist
Position Shift Details:
• Shift Hours: 4 X 10 hours= 12pm - 10pm
• Work Schedule: Thursday thru Sunday/ Monday thru Wednesday off

Purpose
The QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.
Major Accountabilities
• 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.
 

Additional Specifications
• This position involves shift work which will be defined through site business needs.
• Requires flexibility with shifts.
• This position involves on-call shifts, if required, when scheduled.
 

Key Performance Indicators (KPIs)
• On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration

Education & Qualification
Bachelor's Degree, preferably in Life Sciences, chemistry or related relevant degree.

Experiences
2+ years of experience in a GxP Biopharmaceutical manufacturing operations
1+ years of experience in a quality assurance role

• Collaborating across boundaries
• Functional Breadth
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
Competencies
• Continuous Learning (Dyn. Knowledge Development)
• Digital & Technology Savvy
• Operational Excellence
Technical / Function Skills & Knowledge
• Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
• Gmp Procedures.
• QA (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self-Awareness.
• Technological Expertise.
• Technological Intelligence.
• Strong organization, communication and presentation skills.
• Excellent and effective interpersonal skills.

Location: Indianapolis, IN (Onsite)
Pay Rate: $50 - $53/hr based on qualifications based on experience and qualifications (W2 Only)

Position Shift Details:
• Shift Hours: 4 X 10 hours= 12pm - 10pm
• Work Schedule: Thursday thru Sunday/ Monday thru Wednesday off

Contract: 6 month 
Health, dental, vision, 401k

Why Novartis: 
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.