Quality Engineer – Onsite 6-Month Consulting Role

Keystone Industries; Northern (KY); Hybrid; USD 103,000 - 172,000; Full time

Job summary

Keystone Industries in Gibbstown, NJ seeks a Quality Engineer consultant for a 6-month on-site assignment. Hybrid collaboration with process engineers and QA teams will drive equipment qualification, process validation, and documentation.

The selected candidate will support GMP audits and ensure compliance with QMS and FDA CFR requirements. The ideal candidate has 5–10 years in pharmaceutical quality, aseptic processing experience, and strong statistical problem-solving skills to enable

Qualifications

• Minimum 5 years of quality experience in regulated pharma drug manufacturing.
• Experience with sterile processing and cleanrooms preferred.
• Familiarity with QMS, GxP and FDA CFR requirements.
• Ability to apply RCA and statistics to identify causes and implement CAPA.
• Strong design control knowledge: validation, verification and transfer.
• Demonstrated project management and multi-project handling.

Responsibilities

• Coordinate steps to verify technology/design transfer for inter-site production.
• Evaluate processes against regulatory and cGMP requirements and advise improvements.
• Develop validation strategies per regulations and customer needs.
• Develop quality plans using statistical methods and inspection standards.
• Identify and implement process improvements to reduce variation and increase quality.
• Collaborate with process engineers on specs, equipment qualifications, and validation reports.
• Lead RCAs and implement corrective/preventive actions.
• Manage projects and participate in core teams and external audits.

Skills

Quality engineering

GxP

FDA CFR

Root cause analysis

CAPA

Statistical techniques

Process validation

Aseptic processing

Design transfer

Project management

Education

Bachelor's degree

Job description

Keystone Industries in Gibbstown, NJ seeks a Quality Engineer consultant for a 6-month on-site assignment. Hybrid collaboration with process engineers and QA teams will drive equipment qualification, process validation, and documentation.

The selected candidate will support GMP audits and ensure compliance with QMS and FDA CFR requirements. The ideal candidate has 5–10 years in pharmaceutical quality, aseptic processing experience, and strong statistical problem-solving skills to enable