Ismael Mejia
Neptune,NJ
Summary
Dedicated operations manager and effective leader who excels at using proven methods and technology to successfully streamline operations, increase productivity, and cut costs. Results driven professional with extensive experience in production management, production operations, lean manufacturing, product development, and regulatory compliance. Proven expertise in formulation, cost effective manufacturing, process, and procedures.
Overview
14
14
years of professional experience
Work History
Process Manager
Renaissance LLC pharmaceutical
12.2021 - Current
- Responsible for a 24 hour three shift operation and efficient utilization of resources to meet processing demands. Responsibilities include the manufacturing of all products, preparation and sanitization of equipment for all compounding and filling activities, as well as the pre weighing of all required chemicals for manufacturing.
- Ensure the products are produced, stored and released in accordance with approved procedures
- Responsible for authoring, reviewing and/or approving GMP documents including but not limited to SOPs, Batch Records, Labels, Protocols, Reports, Validation documents
- Support and author compliance activities including deviations, CAPAs, Investigation and OOS
- Conducted internal, customer, DEA and FDA audits to verify compliance with quality control standards. Addressed and answered any questions regarding any audit observations.
- Conducted (FMEA) failure mode and effects analysis to identify and address potential problems and their resulting effects in manufacturing processes.
- Reviewed, investigated, and responded to any customer complaints
- Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demands.
- Collaborated with cross-functional teams to ensure smooth implementation of changes in the workflow.
- Implemented new procedures to reduce waste, increase productivity, and enhance customer satisfaction.
Manufacturing Supervisor
Renaissance LLC pharmaceutical
01.2016 - 12.2021
- Supervises the activities of production or plant associates to achieve objectives with regard to quality, cost and time
- Evaluates the performance of associates and complete necessary reports
- Recommends merit increases and training/development needs
- Supervises the utilization of materials to assure an appropriate amount of chemicals and components are available to maintain smooth production flow; identifies wasteful practices and methods; reports any problems/concerns with viable solutions to the Manager.
- Ensured adherence to safety protocols and regulations in the manufacturing process.
- Supervised a team of 30+ employees in the manufacturing area.
- Provided technical guidance to staff on manufacturing processes and troubleshooting issues.
- Conducted employee training sessions on new products or processes introduced in the plant.
- Coordinated with other departments such as Quality Assurance, Procurement. for smooth functioning of operations.
- Managed areas of manufacturing, safety, inventory control and process implementation.
Compounding Technician
DPT/Renaissance LLC
Lakewood, NJ
02.2011 - 12.2015
- follow production record steps outlined to produce sterile product
- operate pumps, filters, scales, and computer systems in order to accurately and aseptically manufacture finished product
- understand and follow good manufacturing practices and standard operating procedures
Education
Associates Degree - Business Administration
Brookdale Community College
01.2012
A - NETWORKING
Teksolv computer School
01.1999
Skills
- Leadership skills and ability to manage staff
- Strong decision making and problem-solving skills
- Efficient utilization of resources to meet processing demands
- Strong attention to detail and ability to work quickly while maintaining a high-priority to the safety of our workforce
- ISO 5 to ISO 8 cleanroom aseptic experience within manufacturing and supporting activities
- experience handling and manufacturing hazardous materials and controlled substances
- bilingual and fluent in English and Spanish
Timeline
Process Manager
Renaissance LLC pharmaceutical
12.2021 - Current
Manufacturing Supervisor
Renaissance LLC pharmaceutical
01.2016 - 12.2021
Compounding Technician
DPT/Renaissance LLC
02.2011 - 12.2015
Associates Degree - Business Administration
Brookdale Community College
A - NETWORKING
Teksolv computer School
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