Mauricio Luna
Kempton,PA
Summary
Senior Specialist with extensive pharmaceutical and chemical experience. Twenty-three years of progressively responsible experience and execution of operational functions.
Overview
20
20
years of professional experience
Work History
Senior Specialist
Catalent Pharmaceuticals
01.2017 - Current
- Responsible for Quality control department and execution of early-stage development batches.
- Perform Quality Control testing and analyst liquids/raw materials.
- Led DEA control substance storing,handling and record upon arrival.
- Complete PDCA quality management and documentation.
- Monitor chart on control rooms,scale calibrations,logbooks and PM on equipment.
- Execute AQL inspections on finish goods as need it.
- Coordinate schedules and proper documentation for upcoming DEA projects to meet customers' needs.
- Accurately conduct QC investigations to avoid re-calls.
- Review/approve forms and documentation to ensure inspections meet the internal and external requirements.
- Use strong technical skills to support logistics labeling hazardous and waste materials (SAP).
Senior Process Associate
Edenbridge Pharmaceuticals
03.2010 - 01.2017
- Primary responsibilities IPA sample testing upon arrival.
- Conduct Quality control documentation, identifying any potential errors.
- Record and communicate results of project updates and other information development staff as necessary.
- Comply with internal Audit
- Perform quality control sample testing ensuring products meet the quality standards.
- Coordinate and label hazardous waste material properly for shipping.
- Responsible for conducting the year-end physical inventory.
- Support lab and stability control department on daily basics.
Production Process Operator
Auro Life Pharmaceuticals
05.2006 - 03.2010
- Conduct set-up operation, dismantling, and cleaning production equipment.
- Assist Formulation Development (Scientist) Services in the execution of experimental batches.
- Focuses on the Daily operation and activities within the drug product development process area.
- Monitor product and process parameters throughout the process and perform teeth sampling.
- Perform experiments to support trials and investigations based on written protocols.
- Serve in the role of Drug Enforcement Agency (DEA) Certified Designated Observer.
- Completing preparation of bulk solutions for cleaning parts Sterilization for entry into the Aseptic Processing Area.
- Perform periodic review on control room, logbooks and scale calibration.
Education
High School Diploma -
Rahway High School
No Degree - Liberal Arts
DeVry University
Seminar Certification -
CFPA Pharmaceutical Seminar
Seminar Sertification - OSHA
Fire Brigade, Hazmat Team, And First Responder Certification
Process Technology for Electronic Materials Certification - Precious Metals
Seminar
Skills
- MS Office Suite
- Project Coordinator
- Communication/Organization
- Drug inventory management
- Quality Control Implementation
- Good Laboratory Practice
- FDA/DEA Safety Guidelines
- Problem Solving
- Logistics Data analysis (SAP)
Timeline
Senior Specialist
Catalent Pharmaceuticals
01.2017 - Current
Senior Process Associate
Edenbridge Pharmaceuticals
03.2010 - 01.2017
Production Process Operator
Auro Life Pharmaceuticals
05.2006 - 03.2010
High School Diploma -
Rahway High School
No Degree - Liberal Arts
DeVry University
Seminar Certification -
CFPA Pharmaceutical Seminar
Seminar Sertification - OSHA
Fire Brigade, Hazmat Team, And First Responder Certification
Process Technology for Electronic Materials Certification - Precious Metals
Seminar