Job Title: Quality Engineer/Quality Specialist Job Description We are seeking a highly experienced and motivated Quality Engineer to join our pharmaceutical manufacturing team. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with a comprehensive understanding of regulatory requirements, quality systems, and process improvements. This role is critical to ensuring compliance with all relevant regulations and standards, leading quality initiatives, and supporting the manufacturing of pharmaceutical products. Responsibilities + Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements. + Ensure all processes and products comply with applicable regulatory standards, including cGMP. + Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance. + 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). + Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings. + Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality standards. + Maintain accurate and comprehensive quality documentation, including SOPs, batch records, and validation protocols. + Mentor and develop junior quality engineers and quality assurance staff, fostering a culture of continuous improvement and quality excellence. + Perform risk assessments and implement risk mitigation strategies related to product quality and regulatory compliance. + 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. Essential Skills + 7-10 years of experience in Quality Assurance within a FDA/GMP environment (pharmaceutical or medical device industry required). + Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required. + Proficiency in quality management software, statistical analysis tools, and methodologies such as Six Sigma and Lean. + Strong understanding of Quality Management Systems. + Experience with Quality Systems including change control, root cause analysis, deviations, documentation management, and training systems. + Experience with electronic Quality and Training Management Systems. + Previous experience with hosting client audits and/or regulatory inspections required with excellent communication skills. Additional Skills & Qualifications + Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred. + Knowledge of FDA, EMA, ICH guidelines, and cGMP regulations. Work Environment This position involves office/desk work in a Monday-Friday role with normal day hours. Flexibility is offered as long as core hours are met. You will have the opportunity to work with large-scale biological and chemistry pharma operations, contributing to impactful work that supports making biologics used for pharmaceutical products. Pay and Benefits The pay range for this position is $42.00 - $72.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Saint Louis,MO. Application Deadline This position is anticipated to close on Jul 7, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.