Operations Support Specialist

Johnson & Johnson Innovative Medicine

Anasco, Puerto Rico, United States of America
Nc/capa investigations and management
Compliance with qsr, gmp, iso standards
Technical leadership in manufacturing operations
Johnson & Johnson is committed to building innovative healthcare solutions that prevent, treat, and cure complex diseases with a focus on personalized and less invasive treatments

Job Summary

  • Johnson & Johnson is committed to building innovative healthcare solutions that prevent, treat, and cure complex diseases with a focus on personalized and less invasive treatments.
  • The role involves leading investigations into non-conformances, corrective and preventive actions, and audit observations to ensure compliance with regulatory standards and improve manufacturing processes.
  • The position requires collaboration with cross-functional teams and manufacturing supervisors to drive quality improvements and maintain compliance with global medical device regulations.

Matching Summary

Johnson & Johnson is committed to building innovative healthcare solutions that prevent, treat, and cure complex diseases with a focus on personalized and less invasive treatments.

Skills & Requirements

Must-have

  • NC/CAPA investigations and management
  • Compliance with QSR, GMP, ISO standards
  • Technical leadership in manufacturing operations
  • Data analysis and trend evaluation
  • Cross-functional team leadership
  • Bilingual Spanish and English

Nice-to-have

  • Strong communication and interpersonal skills
  • Negotiation skills
  • Creativity and initiative
  • Attention to detail
  • Leadership and teamwork
  • Applied statistics and failure mode analysis

Key Requirements

  • Bachelor's Degree required
  • Minimum 4 years experience in NC/CAPA and audit processes
  • Knowledge of FDA 21 CFR and global medical device regulations
  • Experience in regulated medical device manufacturing preferred
  • Bilingual Spanish and English required

Work Rights

Not specified

Tailored Resume

Cover Letter