Quality Assurance Specialist — GMP & Audit Readiness

UNAVAILABLE; East Windsor Township (NJ); On-site; USD 92,000 - 147,000; Full time

Benefits offered by this job

401(k)

Paid time off

Health coverage

Job summary

Hovione, a global CDMO, seeks a Quality Assurance Specialist in New Jersey to ensure cGMP compliance across projects and products. You will support supplier qualification, audits, and regulatory documentation while maintaining rigorous quality systems.

English fluency and strong documentation skills are essential for success in this role. With 3–5 years in QA GMP and a background in Chemistry or related field, you will contribute to product quality, act on CAPAs, and collaborate with

Qualifications

• University qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar field.
• Typically requires 3–5 years of QA GMP experience in the pharmaceutical industry.
• Experience in GMP operations and GMP standards training.
• English fluency is required and strong documentation skills are essential.

Responsibilities

• Ensure cGMP compliance across projects and products.
• Maintain readiness for internal and external audits.
• Coordinate with suppliers and QA to assure quality of materials and products.
• Prepare, review and approve quality documentation and change controls.
• Support investigations of customer complaints and CAPA initiation.

Skills

English fluency

Documentation

Attention to detail

GMP knowledge

MS Office

Education

Chemistry/Pharmaceutical Sciences degree

Tools

MS Office

Job description

Hovione, a global CDMO, seeks a Quality Assurance Specialist in New Jersey to ensure cGMP compliance across projects and products. You will support supplier qualification, audits, and regulatory documentation while maintaining rigorous quality systems.

English fluency and strong documentation skills are essential for success in this role. With 3–5 years in QA GMP and a background in Chemistry or related field, you will contribute to product quality, act on CAPAs, and collaborate with