***Sr. Quality Engineer***

Overview

Lead quality system, compliance, and improvement for pharma manufacturing.

Key Responsibilities

• regulatory compliance
• risk assessment
• audit management
• validation activities
• capa investigation
• supplier qualification

Tasks

-Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all phases of product development and production. -Ensure all processes and products comply with applicable regulatory standards, including cGMP. -Mentor and develop junior quality engineers and quality assurance staff, fostering a culture of continuous improvement and quality excellence. -Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings. -Perform risk assessments and implement risk mitigation strategies related to product quality and regulatory compliance. -Maintain accurate and comprehensive quality documentation, including SOPs, batch records, and validation protocols. -Oversee validation activities, including equipment, process, and cleaning validations, ensuring compliance with industry standards. -Conduct thorough investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). -Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance. -Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements. -Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality standards.

Requirements

• 7-10 years
• fda/gmp
• six sigma
• cqe
• audit experience
• communication

What You Bring

-7-10 years of experience in Quality Assurance within a FDA/GMP environment (pharmaceutical or medical device industry required). -Experience with electronic Quality and Training Management Systems. -Proficiency in quality management software, statistical analysis tools, and methodologies such as Six Sigma, Lean. -Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred. -Previous experience with hosting client audits and/or regulatory inspections. -Strong understanding of Quality Management Systems. -Excellent communication skills. -Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.

People Also Searched For

Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms