Joseph Serrano
Pinellas Park
Summary
Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines.
Overview
15
15
years of professional experience
Work History
Validation Expert
CoreRx
10.2021 - 11.2024
- Led the training of team members on validation principles and techniques, fostering a culture of continuous learning within the organization.
- Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
- Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
- Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
- Developed comprehensive validation plans, outlining objectives, timelines, and resource requirements for successful project execution.
- Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
- Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
- Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
- Enhanced product quality through rigorous testing and data analysis of manufacturing processes.
Compounder
Formulated Solutions
10.2021 - 10.2022
- Established routine maintenance schedules for compounding equipment, reducing downtime due to malfunction or disrepair.
- Contributed to the development of new formulations, enhancing product offerings for customers.
- Enhanced communication between departments, ensuring accurate record-keeping and timely production updates.
- Maintained a safe working environment by following strict safety protocols and conducting regular equipment inspections.
- Operated industrial mixing and power lifting equipment by controlling mixing following instructions.
- Used lift vehicles, power jacks and drummed dollies to complete daily chemical compounding tasks.
- Improved production efficiency by streamlining compound mixing processes and implementing time-saving techniques.
- Prioritized tasks effectively to manage multiple projects simultaneously, resulting in increased workflow efficiency for the entire team.
- Assisted in training new employees on proper compounding techniques, fostering a knowledgeable workforce for improved performance.
Encapsulation Technician
Catalent
08.2016 - 09.2021
- Exceeded daily production targets while consistently meeting quality standards through efficient management of resources.
- Enhanced product quality by performing encapsulation operations and maintaining high standards of cleanliness.
- Participated in ongoing professional development opportunities, staying current with industry trends and advancements in encapsulation technology.
- Supported continuous improvement initiatives by suggesting process improvements and cost-saving measures for the encapsulation department.
- Increased production efficiency by ensuring proper setup, operation, and maintenance of encapsulation machines.
- Facilitated smooth shift transitions by ensuring clear communication between technicians regarding ongoing tasks and pending issues.
- Assisted in training new technicians on encapsulation procedures, contributing to a skilled workforce.
- Maintained a safe work environment by adhering to company safety policies and industry regulations.
- Reduced waste and downtime by troubleshooting equipment issues and implementing timely solutions.
- Implemented preventive maintenance programs on equipment, reducing unforeseen downtimes significantly.
Mold Technician
West Pharmaceuticals
08.2009 - 08.2016
- Streamlined workflow by maintaining an organized and clean work environment for maximum productivity.
- Contributed to cost reduction efforts through effective use of resources and minimal waste generation during molding operations.
- Ensured accurate mold assembly by following detailed blueprints and schematics.
- Increased overall efficiency through proper documentation of mold repairs and modifications.
- Assisted in training new employees on mold setup, operation, and maintenance procedures, fostering a skilled workforce within the department.
- Implemented preventative maintenance schedules for molds, extending their operational life span and reducing repair costs over time.
- Worked closely with Quality Control personnel to address any defects found in molded parts, implementing corrective actions to prevent future occurrences.
Education
High School Diploma -
Nueva Vista
Riverside, CA06.1996
Skills
- CAPA management
- Equipment qualification
- Process validation
- Data integrity
- Cleaning validation
Timeline
Validation Expert
CoreRx
10.2021 - 11.2024
Compounder
Formulated Solutions
10.2021 - 10.2022
Encapsulation Technician
Catalent
08.2016 - 09.2021
Mold Technician
West Pharmaceuticals
08.2009 - 08.2016
High School Diploma -
Nueva Vista