Sr. Quality Engineer (Pharmaceuticals)

Job Title: Senior Quality Engineer Job Description We are seeking a highly experienced and motivated Senior 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). + Bacheloru2019s 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, Lean. + Strong understanding of Quality Management Systems. + Previous experience with hosting client audits and/or regulatory inspections. + Excellent communication skills. Additional Skills & Qualifications + Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred. + Experience with electronic Quality and Training Management Systems. Work Environment This position involves office/desk work with a Monday-Friday schedule and normal day hours. Flexibility is offered as long as core hours are maintained. The work environment supports impactful work and innovative thinking, and is part of a global organization that values passion and unique contributions. Job Type & Location This is a Contract to Hire position based out of Saint Louis, MO. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 Dec 18, 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 ( ) for other accommodation options.

Created: 2025-12-08