Onsite Quality Engineer — 6-Month GMP Consultant

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

Job summary

Keystone Industries in Gibbstown, NJ is seeking a Quality Engineer consultant for a six-month onsite assignment. The role requires 5–10 years of regulated pharma/medical device experience, aseptic processing, equipment qualification, process validation, and SOP development.

The engagement is 1099-based with about 40 hours weekly and no relocation. You will lead quality plans, support audits, and collaborate with process engineers across GMP environments to improve product quality and compliance.

Qualifications

• Minimum 5 years of experience in quality within a regulated pharma/manufacturing environment.
• Experience with aseptic processing and sterile manufacturing.
• Knowledge of QMS, GxP and FDA CFR requirements.
• Ability to lead CAPA and root cause analyses; apply statistics for improvements.
• Strong documentation skills including SOP authoring and process validation.

Responsibilities

• Coordinate steps to verify technology/design transfer for inter-site production and toll manufacturing.
• Evaluate processes against regulatory, customer, and cGMP requirements; influence design with risk-based decisions.
• Develop validation strategies per regulations and customer requirements; resolve complex situations.
• Develop quality plans for components/products using statistical techniques and approved inspection methods.
• Identify and implement process improvements to enhance quality and efficiency.
• Support audits/inspections by notified bodies, customers, suppliers, and internal teams.

Skills

Quality engineering

GMP experience

Statistical analysis

Root cause analysis

Project management

Quality documentation

SOP authoring

Education

Bachelor's degree in Engineering or Science

Tools

CAPA system

Process validation

Equipment qualification

Job description

Keystone Industries in Gibbstown, NJ is seeking a Quality Engineer consultant for a six-month onsite assignment. The role requires 5–10 years of regulated pharma/medical device experience, aseptic processing, equipment qualification, process validation, and SOP development.

The engagement is 1099-based with about 40 hours weekly and no relocation. You will lead quality plans, support audits, and collaborate with process engineers across GMP environments to improve product quality and compliance.