~~~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...
The QA Compliance Specialist implements robust Quality Systems for AAA Indianapolis considering Novartis and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.
• Supports the development and oversight of robust quality systems, including both implementation and operation at site level.
• Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
• Works with the management team to implement and execute the Inspection Readiness program; including Novartis Corporate Inspections and Global Health Authority Inspections.
• Facilitates training on all QA Compliance programs.
• Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level.
• Contributes significantly to the site inspection preparation, program management, response and commitment process.
• Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.
• Performs duties as assigned to ensure compliance to global and local regulations.
• Represent QA Compliance on project teams and in meetings.
• Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
• Adheres to all GMP requirements.
• Other related duties as assigned.
Education & Qualification
B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
Experiences
8+ years of experience in a GMP Biopharmaceutical environment
2+ years of experience in a Quality Assurance role
• Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues.
• Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance.
• Previous experience in QA Compliance including self-inspections, preferred.
• Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
• Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
• Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
• Strong follow-up and organizational skills.
• Experience with radiopharmaceutical therapies a plus.
• Direct experience reviewing and/or authoring standard operating procedures.
• Ability to work well independently and within a team.
• Excellent oral and written communication skills with technical writing experience required.
Location: Indianapolis, IN (Onsite)
Pay Rate: $40 - $51/hr based on experience and qualifications (W2 Only)
Contract: 4 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.
