Controlled Substance Specialist

Johnson & Johnson

Gurabo, Puerto Rico, United States of America
Not specified
Controlled substance program management
Fda/gmp/dea regulations
Regulatory agency reporting
Johnson & Johnson is seeking a Controlled Substance Specialist in Gurabo, Puerto Rico, to manage compliance with regulations related to controlled substances. The role requires a bachelor's degree in a science-related field and at least one year of relevant experience in the pharmaceutical industry

Job Summary

  • The Controlled Substance Specialist is responsible for managing the Controlled Substance program to ensure compliance with current Good Manufacturing Practice (GMP) guidelines, as well as corporate standard operating procedures, policies, rules, and regulations.
  • You will be responsible for staying updated on FDA/GMP/DEA regulations and coordinating with DEA/ASSMCA for on-site visits to assess facility/process changes affecting controlled substances.
  • This role requires providing regulatory/compliance guidance and leadership to support company processes and achieving goals set by the quality team and overall business and process goals.

Matching Summary

Match Score: 80

Johnson & Johnson is seeking a Controlled Substance Specialist in Gurabo, Puerto Rico, to manage compliance with regulations related to controlled substances. The role requires a bachelor's degree in a science-related field and at least one year of relevant experience in the pharmaceutical industry.

Skills & Requirements

Must-have

  • Controlled Substance Program Management
  • FDA/GMP/DEA Regulations
  • Regulatory Agency Reporting
  • SOP and Change Control Review
  • Internal Audit Program Support

Nice-to-have

  • Action-Oriented
  • Detail-Oriented
  • Critical Thinking
  • Operational Excellence
  • Process Improvements

Key Requirements

  • Bachelor's degree in science
  • 1 year of related working experience
  • English and Spanish communication skills

Work Rights

PR required

Tailored Resume

Cover Letter