QA for QC, QA Operations

U469 (FCRS = US469) AAA USA Inc.; Millburn (NJ); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis is seeking a QA professional to provide quality oversight across Quality Control testing activities and partner with laboratory teams to ensure data integrity and compliance. You will review critical records, support investigations and change control, and drive operational excellence in laboratory operations.

The role requires a Bachelor’s degree in a scientific field and several years in pharma QA/QC, with strong GMP knowledge and cross-functional collaboration.

Qualifications

• Bachelor’s degree or higher in a scientific discipline.
• Several years of experience in pharmaceutical quality assurance, quality control, or manufacturing environments.
• Strong knowledge of GMP, quality systems, and regulatory compliance.

Responsibilities

• Provide quality assurance oversight for Quality Control testing activities to ensure compliance and inspection readiness.
• Partner with laboratory teams to promote data integrity, electronic compliance, and quality standards.
• Review and approve Quality Control and Analytical Science and Technology records accurately and timely.
• Support and assess investigations related to Quality Control deviations and quality events.
• Review and support change control activities impacting Quality Control processes and systems.
• Contribute to operational excellence and continuous improvement initiatives across laboratory operations.
• Promote a strong safety culture through compliance with Health, Safety, and Environment requirements.

Skills

Collaboration

Communication

Data Integrity

GMP

Internal Quality Auditing

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

Quality Management Systems

Regulatory Compliance

SOP

SPC

English Proficiency

Education

Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or related

Job description

Band Level 3 Job Description Summary Location: Millburn, NJ Relocation Support: This role is based in Millburn, NJ. Novartis is unable to offer relocation support: please only apply if accessible.

Imagine being the trusted quality partner who helps ensure every test result supports the delivery of safe, high-quality medicines to patients.

As QA for QC, QA Operations, you will play a critical role in providing quality oversight for Quality Control testing activities, driving compliance, data integrity, and continuous improvement across laboratory operations.

Working closely with Quality Control and Analytical Science and Technology teams, you will review and approve critical records, support investigations and change activities, and help maintain the highest standards of quality, compliance, and operational excellence in a collaborative and purpose-driven environment.

Job Description Key Responsibilities

• Provide quality assurance oversight for Quality Control testing activities to ensure compliance and inspection readiness.
• Partner with laboratory teams to promote data integrity, electronic compliance, and quality standards.
• Review and approve Quality Control and Analytical Science and Technology records accurately and timely.
• Support and assess investigations related to Quality Control deviations and quality events.
• Review and support change control activities impacting Quality Control processes and systems.
• Contribute to operational excellence and continuous improvement initiatives across laboratory operations.
• Promote a strong safety culture through compliance with Health, Safety, and Environment requirements.

Essential Requirements

• Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or a related scientific discipline.
• Several years of experience in pharmaceutical quality assurance, quality control, or manufacturing environments.
• Strong knowledge of Good Manufacturing Practice requirements, quality systems, and regulatory compliance standards.
• Demonstrated ability to collaborate across functions and support operational excellence initiatives.
• Strong written and verbal communication skills in English, with the ability to work effectively in a team environment.

Desirable Requirements

• Experience within a Radioligand Therapy manufacturing environment.
• Experience reviewing quality records, investigations, deviations, and change control activities.

The salary for this position is expected to range between $89,600 and $166,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.

Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.

In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Salary Range $89,600.00 - $166,400.00

Skills Desired

• Collaboration
• Communication
• Data Integrity
• Good Manufacturing Practices (GMP)
• Internal Quality Auditing
• Managing Ambiguity
• Operational Excellence
• Quality Assurance (QA)
• Quality Compliance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Compliance
• Standard Operating Procedure (SOP)
• Statistical Process Control (SPC)

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .