QA for QC Operations - Lab Quality Assurance Lead

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

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.