Clinical QA Auditor – Hybrid, GMP Oversight

The Fountain Group; Rahway (NJ); Hybride; USD 52 000 - 58 000; Temps partiel

Résumé du poste

The Fountain Group is seeking a Quality Assurance Specialist in Rahway, NJ, on a 23-month contract with a hybrid work arrangement. The role entails providing GMP‑compliant quality oversight for clinical‑stage drug product manufacturing, testing, and release, coordinating with cross‑functional teams to ensure regulatory compliance and continuous improvement.

The ideal candidate will have a Bachelor’s degree in a Science or Engineering field and at least 3 years of QA/QA‑Ops experience in

Qualifications

• Bachelor's degree in Science or Engineering required.
• Minimum 3 years’ experience preferred; recent grads considered.
• Experience in pharmaceutical/biotech/chemical/medical device industries.
• Experience in Quality Assurance, Quality Control, or Regulatory Affairs.
• Knowledge of cGMP, drug regulations, and regulated quality systems.
• Familiarity with R&D or clinical supply operations.

Responsabilités

• Support GDQ Ops quality oversight for manufacturing, testing, and release of clinical-stage products.
• Review batch records, CoAs, and quality documentation to determine product disposition.
• Perform QA activities including deviations, investigations, CAPAs, and audits.
• Ensure compliance with cGMP, ICH guidelines and internal policies.
• Communicate quality issues and risks to stakeholders; escalate when needed.
• Develop, write, and edit SOPs and GMP-controlled documents.
• Support quality system metrics and continuous improvement initiatives.
• Coordinate meetings and manage multiple quality review assignments.

Connaissances

Quality Assurance

GMP knowledge

Regulatory compliance

Quality documentation

Batch disposition

CAPA & investigations

Data analysis

Cross-functional collaboration

Risk management

Communication

Formation

Bachelor's degree in Science or Engineering

Outils

SAP

Veeva

Description du poste

The Fountain Group is seeking a Quality Assurance Specialist in Rahway, NJ, on a 23-month contract with a hybrid work arrangement. The role entails providing GMP‑compliant quality oversight for clinical‑stage drug product manufacturing, testing, and release, coordinating with cross‑functional teams to ensure regulatory compliance and continuous improvement.

The ideal candidate will have a Bachelor’s degree in a Science or Engineering field and at least 3 years of QA/QA‑Ops experience in