Senior Quality Engineer - Regulated Manufacturing & CAPA

Advantage Technical; Lexington (KY); On-site; USD 61,000 - 68,000; Full time

Job summary

Advantage Technical is seeking a Senior Quality Engineer for a contract-to-hire opportunity with a regulated manufacturing organization in Lexington, KY. The role focuses on supporting site QA programs, regulatory compliance, customer quality activities, and continuous improvement initiatives.

Strong background in pharmaceutical, biotechnology, chemical, or similarly regulated environments is preferred, with experience in cGMP and ISO-based systems.

Qualifications

• Minimum of 5 years in Quality Engineering or related QA experience.
• Experience in pharmaceutical/biotech/chemical or regulated manufacturing environments.
• Strong background in cGMP and ISO-regulated quality systems.
• Experience supporting CAPA, investigations, audits, and validation activities.
• Excellent problem-solving and data analysis skills.

Responsibilities

• Support implementation and continuous improvement of QA programs and processes.
• Ensure compliance with cGMP, ISO standards, FDA expectations, and internal procedures.
• Develop and improve inspection methods, testing, validation, and QC procedures.
• Lead CAPA investigations, root-cause analysis, and preventive actions.
• Investigate manufacturing and product-quality issues and establish durable solutions.
• Support complaint investigations and timely customer responses.

Skills

Quality Engineering

Regulatory Compliance

CAPA Investigations

Root Cause Analysis

SOP Documentation

Statistical Methods

SPC

Job description

Advantage Technical is seeking a Senior Quality Engineer for a contract-to-hire opportunity with a regulated manufacturing organization in Lexington, KY. The role focuses on supporting site QA programs, regulatory compliance, customer quality activities, and continuous improvement initiatives.

Strong background in pharmaceutical, biotechnology, chemical, or similarly regulated environments is preferred, with experience in cGMP and ISO-based systems.