Quality Engineer

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

Contract-to-Hire Opportunity | Advantage Technical

Schedule: 1st Shift, Monday–Friday

Pay Rate: Up to approximately $44-49/hour

Position Overview

Advantage Technical is partnering with a regulated manufacturing organization to identify an experienced Senior Quality Engineer for a contract-to-hire opportunity.

This role will support site Quality Assurance programs, regulatory compliance, customer quality activities, process improvement, validation, investigations, and continuous improvement initiatives. The Senior Quality Engineer will work cross-functionally with Manufacturing, Engineering, Operations, Regulatory, Suppliers, and customers to improve product quality, strengthen quality systems, and support compliant manufacturing operations.

The ideal candidate will bring strong experience working in pharmaceutical, biotechnology, chemical, or similarly regulated manufacturing environments and will be comfortable working within cGMP and ISO-based quality systems.

Key Responsibilities

• Support implementation and continuous improvement of site Quality Assurance programs and processes.
• Ensure compliance with applicable quality standards, internal procedures, cGMP requirements, ISO standards, FDA expectations, and other applicable regulatory requirements.
• Develop, implement, and improve inspection methods, testing processes, validation activities, and quality-control procedures.
• Lead and support CAPA investigations, root cause analysis, corrective actions, and preventive improvement initiatives.
• Investigate manufacturing and product-quality issues and develop sustainable solutions to prevent recurrence.
• Support complaint investigations and customer responses, ensuring issues are investigated thoroughly and resolved in a timely manner.
• Serve as a key Quality contact for customers, suppliers, vendors, and regulatory or certification organizations.
• Lead or support customer audits, certification audits, surveillance audits, and internal audits.
• Support supplier-quality activities, including supplier audits, issue resolution, and performance improvement.
• Coordinate and support process-validation and quality-validation initiatives.
• Apply statistical methods and SPC techniques to evaluate process performance, identify trends, and support data-driven quality decisions.
• Analyze product, process, and testing data to identify quality trends and opportunities for improvement.
• Support development, revision, and implementation of SOPs, quality procedures, and controlled documentation.
• Identify opportunities to improve defect detection, process capability, testing effectiveness, and corrective-action workflows.
• Support stability, validation, quality-system, and compliance activities as required.
• Work with cross-functional teams to balance product quality, manufacturing efficiency, regulatory requirements, and customer expectations.
• Provide Quality Engineering leadership and technical guidance on complex manufacturing and compliance issues.
• Drive continuous improvement initiatives focused on quality, compliance, process consistency, and operational effectiveness.

Quality Systems & Regulatory Support

The Senior Quality Engineer will provide direct support to quality systems and activities that may include:

• CAPA
• cGMP compliance
• ISO Quality Systems
• Stability Programs
• Statistical Process Control
• Process Validation
• Internal & External Audits
• Corrective and Preventive Action
• Quality Documentation

Required Qualifications

• Minimum of 5 years of Quality Engineering or related Quality Assurance experience.
• Experience working in pharmaceutical, biotechnology, chemical, or similarly regulated manufacturing environments.
• Strong experience working within cGMP and ISO-regulated quality systems.
• Experience supporting CAPA, investigations, audits, complaint handling, and validation activities.
• Strong problem-solving and root-cause-analysis skills.
• Experience analyzing manufacturing or quality data and identifying trends.
• Ability to manage multiple Quality projects and priorities simultaneously.
• Strong written and verbal communication skills.
• Comfortable interacting directly with customers, suppliers, auditors, and internal stakeholders.
• Ability to work independently while collaborating effectively across departments.

Preferred Experience

• Experience with ICH Q7, IPEC guidance, FDA requirements, and ISO 9000-series standards.
• Experience supporting pharmaceutical, reagent, chemical, or highly regulated manufacturing operations.
• Experience with SPC and statistical quality methods.
• Experience conducting or hosting supplier, customer, certification, or regulatory audits.
• Experience developing or improving Quality procedures, SOPs, inspection methods, and testing protocols.

This is a contract-to-hire opportunity through Advantage Technical with an established regulated manufacturing organization.

Schedule: 1st Shift, Monday–Friday

Pay: Up to approximately $44/hour, depending on experience and qualifications.