QA Engineer

QA EngineerThe QA Engineer develops, maintains, and continuously improves quality management systems and processes to ensure full compliance with FDA regulations and current GMP requirements. This role focuses on quality systems in a GMP manufacturing environment, supporting both manufacturing and distribution operations, driving investigations and CAPAs, and contributing to process optimization and continuous improvement while managing projects and timelines effectively.ResponsibilitiesDevelop, monitor, and improve quality management systems and processes to ensure compliance with FDA regulations and current GMP requirements.Ensure GMP-required documentation adheres to applicable governmental regulations related to food, drug, and cosmetic industries.Monitor and interpret the Federal Register and other regulatory sources to stay current on laws and guidance affecting quality and compliance.Define and improve systems and processes to strengthen the overall quality system and operational efficiency.Maintain the quality system for Process Variance Reports (PVR) across manufacturing and distribution locations.Generate and maintain Annual Product Reviews (APR) for relevant products and facilities.Conduct and support customer complaint investigations, ensuring timely, thorough, and well-documented outcomes.Maintain and update quality attributes within customer specification portals to ensure accurate and compliant product information.Develop or assist with process control procedures and automation specifications to support ongoing compliance and robust process control.Evaluate data from current processes to recommend improvements that enhance cost effectiveness and production quality.Investigate root causes of quality issues, write and implement CAPAs, and collaborate with cross-functional departments to ensure effective resolution.Respond promptly to quality events and deliver high-quality investigations and comprehensive CAPA documentation.Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) studies to assess systems and processes and identify potential risks.Assist in GMP and GDP training for new personnel, reinforcing quality and documentation best practices.Create or modify standard operating procedures (SOPs) and work instructions, and recommend changes to batching instructions as needed.Perform statistical process analysis to evaluate process control and identify opportunities for improvement.Coordinate resources and communicate project progress using project management tools and techniques for multiple concurrent projects.Participate in or support internal and external audits of manufacturing areas, including FDA and customer audits, and contribute to deviation and complaint investigations.Exhibit strong team player qualities by cooperating and coordinating with colleagues and maintaining professional interaction in all business contacts.Essential SkillsBachelor's degree in a related science or engineering field.A minimum of 1–3 years of quality experience in a GMP manufacturing environment (such as food, consumer products, cosmetics, or pharmaceuticals) strongly preferred.Hands-on experience with quality systems, including CAPA, deviations, auditing, and complaint management.Solid knowledge of current GMPs and FDA regulations and the ability to develop technically compliant documents.Experience participating in FDA or customer audits with an understanding of audit expectations and requirements.Broad quality assurance experience in quality systems, with the ability to manage projects and drive processes forward.Demonstrated ability to function effectively both as an individual contributor and as a collaborative team member.Strong project management skills, including the ability to coordinate resources and communicate progress across multiple projects.Comfort with escalating issues when necessary to ensure timely resolution and compliance.Proficiency in Microsoft Office products for documentation, analysis, and communication.Ability to perform statistical process analysis and interpret data to support process control and improvement.Strong investigative mindset with the ability to identify root causes and develop effective CAPAs.Excellent communication and interpersonal skills to support cross-functional collaboration and professional interactions.Additional Skills & QualificationsAuditing experience in manufacturing areas or involvement in quality investigations (complaints, deviations, etc.) strongly preferred, even if not the primary investigator.Experience with Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) studies.Experience generating and maintaining Process Variance Reports (PVR) and Annual Product Reviews (APR).Experience creating, modifying, and implementing SOPs, work instructions, and batching instructions.Exposure to customer complaint management and maintaining quality attributes in customer specification portals.Experience supporting GMP and GDP training for new personnel.Ability to work in a continuous improvement environment, contributing ideas and actions to enhance systems and processes.Willingness to take on a variety of tasks, including time on the manufacturing floor when needed, and flexibility to stay late or support overtime as required.Strong sense of ownership and accountability for quality outcomes and project deliverables.Eligibility and interest in a contract-to-hire arrangement with potential for long-term growth and participation in company ownership programs.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 $30.00 - $30.00/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 Aug 19, 2026.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.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 process due to a disability, please email View email address on click.appcast.io for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.