QA for QC, QA Operations

DTX Pharma, a Novartis Company; Millburn (NJ); Sur place; USD 90 000 - 166 000; Plein temps

Avantages offerts par ce poste

Incentives

401(k) Matching

Health benefits

Disability insurance

Résumé du poste

Novartis is seeking a QA professional to provide quality oversight for Quality Control testing, ensuring data integrity and compliance across laboratory operations in Millburn, NJ. The role collaborates with QC and Analytical Science and Technology teams to review records, support investigations, and drive change controls with a focus on continuous improvement.

The position requires a Bachelor's degree in a related scientific field, several years of QA/QC experience, and strong GMP knowledge.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Collaboration

Communication

Data Integrity

GMP

Internal Quality Auditing

Managing Ambiguity

Operational Excellence

QA

Quality Compliance

Quality Control (QC)

Quality Management Systems (QMS)

Regulatory Compliance

SOP

SPC

Formation

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

Description du poste

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.

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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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)