Johnson & Johnson is seeking a Controlled Substance Specialist in Gurabo, Puerto Rico, to manage compliance with Good Manufacturing Practice (GMP) guidelines and internal procedures regarding controlled substances. The ideal candidate will possess a science degree and relevant experience in compliance within 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.
Act as a compliance representative in plant-wide project teams and New Products activities, particularly those related to controlled substances, and provide regulatory/compliance guidance and leadership.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Controlled Substance Specialist in Gurabo, Puerto Rico, to manage compliance with Good Manufacturing Practice (GMP) guidelines and internal procedures regarding controlled substances. The ideal candidate will possess a science degree and relevant experience in compliance within 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
Business Process Design
Critical Thinking
Execution Focus
Operational Excellence
Key Requirements
Bachelor's degree in science
1 year of related working experience
Strong knowledge of GMPs and regulations
Excellent oral and written communication skills in English and Spanish