QA Specialist

QA EngineerThe QA Engineer supports the development, maintenance, and continuous improvement of quality systems and processes within a GMP-regulated manufacturing environment. This role partners with Quality, Manufacturing, Operations, and Technical teams to ensure compliance with regulatory requirements while driving investigations, corrective actions, process improvements, and quality system effectiveness. The successful candidate will contribute to quality assurance activities including CAPA management, deviation investigations, documentation control, audit readiness, and continuous improvement initiatives. This position offers an excellent opportunity for early-career professionals to build expertise in GMP quality systems, regulatory compliance, and operational excellence.Key ResponsibilitiesSupport the development, implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes and procedures.Assist in ensuring compliance with FDA regulations, GMP requirements, and internal quality standards.Conduct investigations related to deviations, customer complaints, process variances, and quality events.Perform root cause analysis and support the development, implementation, and effectiveness verification of Corrective and Preventive Actions (CAPAs).Maintain quality system documentation including reports, investigations, SOPs, work instructions, and quality records.Support the generation and maintenance of Annual Product Reviews (APRs), Process Variance Reports (PVRs), and other quality metrics.Analyze process and quality data to identify trends, risks, and opportunities for improvement.Participate in continuous improvement initiatives focused on enhancing product quality, process performance, and operational efficiency.Collaborate with Manufacturing, Engineering, Regulatory, Supply Chain, and Quality teams to resolve quality-related issues.Assist with internal audits, customer audits, regulatory inspections, and audit readiness activities.Support training activities related to GMP, GDP, and quality system requirements.Create, revise, and maintain SOPs, work instructions, forms, and controlled documentation.Apply quality risk management principles and support risk assessments as needed.Effectively manage multiple projects, priorities, and timelines while maintaining high-quality deliverables.Required QualificationsBachelor's degree in Engineering, Chemistry, Biology, Microbiology, Food Science, Pharmaceutical Sciences, Chemical Engineering, Industrial Engineering, or a related scientific discipline.Experience supporting quality, manufacturing, laboratory, engineering, validation, process improvement, or regulatory activities through industry experience, internships, co-ops, academic research, or equivalent experience.Strong analytical and problem-solving skills.Ability to collect, analyze, and interpret technical data.Strong written and verbal communication skills.Ability to write clear and technically accurate documentation.Attention to detail and strong organizational skills.Proficiency with Microsoft Office applications including Excel, Word, Outlook, and PowerPoint.Ability to work independently and effectively within cross-functional teams.Preferred QualificationsExperience in a GMP-regulated environment including pharmaceutical, biotechnology, food, cosmetics, consumer products, or medical device manufacturing.Experience with CAPA, deviations, nonconformances, change controls, or complaint investigations.Familiarity with FDA regulations, GMP requirements, and quality management systems.Experience supporting internal audits, customer audits, or regulatory inspections.Exposure to root cause analysis methodologies.Experience performing data trending and statistical analysis.Knowledge of quality risk management tools such as FMEA or HAZOP.Experience generating quality reports, APRs, PVRs, or similar documentation.Experience creating or revising SOPs, work instructions, and controlled documents.Familiarity with electronic quality management systems (eQMS) or document management systems.Key CompetenciesQuality Management SystemsRoot Cause AnalysisCAPA ManagementDocumentation & ComplianceGMP & Regulatory ComplianceAudit ReadinessContinuous ImprovementData AnalysisProject ManagementProblem SolvingCollaboration & TeamworkTechnical CommunicationJob 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 27, 2026.