Quality Systems Associate 2 - Training

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements.
• Create and update training materials, including SOP-based training modules, curricula, and assessments.
• Oversee onboarding and continuous training programs for new and existing employees.
• Generate routine training compliance reports and escalate gaps to management.
• Assist in preparing for internal audits; support readiness for external audits and inspections.
• Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications.
• Support management of deviations, non conformances, and audit findings, ensuring documentation is accurate and complete.
• Collaborate with cross functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements.
• Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement.
• Assist with the administration of quality system software, including user access management, record maintenance, and troubleshooting.
• Stay informed on evolving regulations, guidance documents, and industry best practices.
• Perform other duties and responsibilities as assigned to support departmental and organizational objectives.

Required Skills

•  Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum 3+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.).
• Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards.
• Proven experience creating and updating training materials, including SOP-based training modules, curricula, and assessments.
• Oversee onboarding and continuous training programs for new and existing employees.
• Generate routine training compliance reports and escalate gaps to management.
• Ability to work independently and collaboratively in a fast paced environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Experience with QMS or electronic quality system software platforms (QT9/Veeva preferred).
• Strong written and verbal communication skills for effective cross functional collaboration.

Preferred / Nice-to-Have Skills

•    Experience in a GMP manufacturing, biologics, or cell therapy environment.
•    Exposure to ISO audit practices or participation in internal audits.
•    Ability to analyze quality data, produce reports, and identify trends.

Work Environment / Physical Demands

•    Primarily office based, focusing on quality system management and training activities.
•    Requires prolonged periods of computer use for documentation, reporting, and system administration.
•    Occasional lifting of office materials up to 15 pounds.
•    Ability to move between office and operational areas to support audits and cross functional work.