Job Description

Quality Assurance(QA) Operations Specialist- Multiple positions available

Location: Millburn, NJ #LI-Onsite

About this role:

This is an exciting opportunity to join our Quality Assurance Team as a QA Operations Specialist. You will be responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.

Key Responsibilities:

• Provide shop floor 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 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.

Additional Specifications

• This position involves shift work which will be defined through site start up and commercialization readiness.
• This position involves on-call shifts, if required, when scheduled.

NOTE: This is a 1st shift position, however days and hours may vary

Minimum requirements

Essential Requirements
Education: Bachelors\' Degree, preferably in Life Sciences, chemistry or related relevant degree.

Experience:
2+ years of experience in a GxP Biopharmaceutical manufacturing operations
1+ years of experience in a quality assurance role
Experience working in a matrixed organization
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones

The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an \xe2\x80\x9cat-will position\xe2\x80\x9d and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\'s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You\'ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients\' lives by leading innovation in nuclear medicine.
Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Functional Area

Quality

Division

Operations

Business Unit

QUALITY

Employment Type

Regular

Shift Work

Yes

Early Talent

Yes

Novartis