QA Engineer – Compliance Specialist Position Available In St. Louis City, Missouri

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QA Engineer – Compliance Specialist Job Description This role is pivotal in ensuring compliance with sight quality records, adhering to stringent requirements and regulations. The position involves participating in site inspection readiness activities, conducting internal audits of Quality systems and GMP functions, supporting client audits, and implementing corrective actions. The role guarantees overall compliance with FDA, EMA, and other cGMP regulations. Responsibilities Ensure compliance with FDA, EMA, and other cGMP regulations and client requirements. Oversee Site Quality Records to ensure timely completion and adherence to requirements, including CAPA, audits, and change control. Lead and participate in site internal audits, including executing, approving responses, and supervising remediation activities. Support or lead client audits or inspections. Approve corrective action plans and effectiveness checks for Quality System CAPAs. Author, review, or approve documents within eDMS as needed. Participate in inspection readiness tasks and regulatory inspections. Provide expertise on current cGMP requirements and trends to support quality/compliance matters at the site. Train and mentor junior staff members. Essential Skills Quality assurance and quality management system expertise. Experience in a GMP or regulated industry. Proficiency in Quality Systems including change control, deviations, documentation management, and training systems. Experience with electronic Quality and Training Management Systems, quality control, and inspection. In-depth knowledge of FDA/EMA regulatory requirements. Strong understanding of Quality Management Systems. Previous experience with hosting client audits and regulatory inspections. Additional Skills & Qualifications Bachelor’s degree in a scientific field such as Life Sciences or Biotechnology. 5+ years of experience within a GMP Environment, preferably pharmaceutical. Confirmed experience within Quality Assurance or Compliance. At least 2 years of experience in conducting internal audits. Work Environment Join a dynamic team engaged in large-scale biological and chemistry pharmaceutical operations. The work environment is innovative, with a culture dedicated to impactful work and customer-centric values. The organization supports making biologics for pharmaceuticals addressing major health issues. Employees are empowered to realize their potential in a fast-growing, global organization that values passion and unique contributions. The company offers resources and opportunities for career growth while making a difference in the world.