On-Site GMP Quality Engineer Consultant (Pharma/Devices)

Keystone Industries; Gibbstown (NJ); On-site; USD 103,000 - 172,000; Full time

Job summary

Keystone Industries in Gibbstown, NJ seeks a Quality Engineer/Consultant for an approximately six‑month, on‑site engagement. The role requires 5–10 years in regulated pharma/manufacturing, aseptic processing experience, and strong QA/QC and regulatory knowledge.

The consultant will work in a GMP environment, support audits, lead CAPA and MRB activities, and collaborate with engineers on validation and process improvements. Compensation is hourly and flexible for highly qualified candidates.

Qualifications

• Minimum 5 years in Quality within regulated pharma/manufacturing environments.
• Experience with aseptic processing and cleanrooms is preferred.
• Strong understanding of QMS, GxP and FDA CFR requirements.

Responsibilities

• Coordinate tech transfer steps for inter-site production and toll manufacturing.
• Evaluate new processes against regulatory and cGMP requirements; influence process design.
• Develop validation strategies compliant with regulations and customer requirements.
• Create quality plans using statistical techniques and approved inspection methods.
• Identify and implement process improvements to enhance product quality and efficiency.
• Collaborate with process engineers to approve specifications, equipment qualifications and validation protocols.
• Oversee protocol execution and evaluate engineering change controls.
• Lead root cause analyses and implement corrective/preventive actions.
• Assess process risk and prepare risk assessments; manage project teams and audits.

Skills

QA/QC

Regulatory compliance

Root cause analysis

Statistical methods

Process validation

Education

Bachelor's degree

LEAN/Six-Sigma Training/Certification

QE certification (preferred)

Tools

Microsoft Office Suite

Job description

Keystone Industries in Gibbstown, NJ seeks a Quality Engineer/Consultant for an approximately six‑month, on‑site engagement. The role requires 5–10 years in regulated pharma/manufacturing, aseptic processing experience, and strong QA/QC and regulatory knowledge.

The consultant will work in a GMP environment, support audits, lead CAPA and MRB activities, and collaborate with engineers on validation and process improvements. Compensation is hourly and flexible for highly qualified candidates.