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 elevate 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.
#j-18808-ljbffr