Mayra Solivan
Alexandria
Summary
Responsible Technician with excellent troubleshooting, customer service and analytics skills coupled with more than 24 years of experience. Highly effective in complying with safety requirements evidenced by zero work loss days. Broad skills in maintenance and bench builds.
Overview
24
24
years of professional experience
Work History
Manufacuring Technician III
Granules Pharmaceutical
01.2023 - Current
- Follow Master Batch Records for the manufacturing of controlled, oral solid dose (OSD) and other dosage forms when required
- Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures
- Operates scales including set-up, verification, leveling and challenging
- Identify, report, and resolve quality issues
- Safely and in compliance with batch records and SOPs, set up, operate, and clean packaging equipment
- Perform in-process testing and inspections as required by Master Batch Record
- Clean and sanitize manufacturing and packaging rooms including walls, floors, and ceilings per SOPs
- Report accidents and unsafe conditions or unusual circumstances to supervisor
- Complete accurate and timely documentation
- Follow good documentation practices in accordance with GMP
- Handle labeling and components correctly; transferring, counting, FIFO, returns, etc
- During packaging processes
- Actively participate in Production team and Site communication meetings
- Support GMP investigations and events
- Identify and report potential GMP impacting situations
- Contribute to Standard Operating Procedure (SOP) writing in your technical area.
- Ensure documentations are completed in real time in accordance to cGMP and GDP
- Sanitize clean room
- Trobleshooting
Novartis
Manufacturing Technician II
07.2022 - 12.2022
- Troubleshot equipment issues, minimizing downtime and maintaining optimal production levels in a fast-paced environment. Running Bosch 2000, 2500 assembly and disassembly
- Encapsulation operations with excellent cGMP practices and documentation practices in batch recording processes. Troubleshooting skills performed on the IMA, Bosch encapsulation equipment operations. Setup technician. Running validation batch, reconcile clean and sanitize the clean room
- Documented in real time
- Collected samples to laboratory according to batch record
- Daily take calibrate scales to be used
- Rinse and swab cleaning
- Use appropriate gowning PPE
- clean, setup and operate all related equipment in the encapsulation area
- Documented all activity in MES
Manufacturing Technician
Jubilant Cadista Pharmaceuticals
02.2013 - 10.2020
- Maintained a safe work environment by enforcing safety protocols and conducting routine inspections.
- Troubleshot equipment issues, minimizing downtime and keeping production on track to meet deadlines.
- Made sure that products were produced on time and are of good quality.
- Increased overall productivity by training new technicians and providing ongoing support to team members.
- Assembled and tested parts and components to meet safety and performance standards.
- Recorded and documented all maintenance activities in accordance with company policies and procedures.
- Performed routine equipment calibration to maintain consistent product quality and adherence to specifications.
- Documented all manufacturing activities, maintaining accurate records for reporting purposes and quality assurance audits.
- Utilized Lean Manufacturing principles to eliminate inefficiencies and maximize productivity throughout the facility.
Manufacuring Operator
Amgen Biotechnology Pharmaceutical
09.2012 - 01.2013
- Operated machining equipment safely with team of operators.
- Trained new employees on company policies, equipment operation, and best practices, fostering a positive work environment and team cohesion.
- Set up and ran machinery to produce exceptional products for industrial needs.
- Inspected products and machines to maintain quality and efficiency.
- Syringes and vials inspection to visualize foreign particle's
- Packaging shortclicks
- Clean and sanitize room
- Reconcile
- Documented all activity in the electronic batch record in the system
- Use the appropriate gowning
Manufacturing Operator
Mylan Pharmaceuticals
05.2010 - 01.2013
- Operated machining equipment safely with team of operators.
- Trained new employees on company policies, equipment operation, and best practices, fostering a positive work environment and team cohesion.
- Inspected products and machines to maintain quality and efficiency.
- Set up and ran machinery to produce exceptional products for industrial needs.
- Examined incoming materials and compared to documentation for accuracy and quality.
- Collaborated with Quality Assurance teams in conducting regular inspections of finished products, ensuring all items met established quality standards.
- Increased output rate by adjusting machine settings for optimal performance during high-volume production runs.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Set up and adjusted equipment and properly configured machines for daily operation.
- Organized and prepared workstations and materials needed for operations to maximize productivity.
- Adjusted machines to increase productivity for runs.
- Ran encapsulation H&K machine, checkweigher. use the PPE run different batches, validations and protocols documented all activity in the batch record
Manufacturing Operator
Janssen Pharmaceuticals
04.2008 - 04.2009
- Operated machining equipment safely with team of operators.
- Inspected products and machines to maintain quality and efficiency.
- Set up and ran machinery to produce exceptional products for industrial needs.
- Assisted in maintaining a clean workplace environment free from debris and hazards by closely following housekeeping protocols.
- Operated multiple machines simultaneously to meet production requirements.
- Set up and adjusted equipment and properly configured machines for daily operation.
- Clean and sanitize the clean room
- Use the appropriate PPE all the time
- Documented all the activity in SAP program
Technical Packaging Lead
Warner Chilcott Pharmaceuticals
02.2001 - 03.2008
- Developed innovative package designs for improved consumer experience and functionality.
- Enhanced product quality through rigorous testing and continuous improvement of packaging materials.
- Managed complex projects with tight deadlines, consistently delivering on time while maintaining high standards of quality control.
- Streamlined operational workflows, resulting in increased productivity and reduced waste.
- Improved packaging efficiency by implementing new technical solutions and automation processes.
- Resolved technical issues promptly, minimizing disruptions to production schedules and customer deliveries.
- Implemented safety protocols to minimize workplace accidents and ensure employee wellbeing.
- Labeled packages with appropriate shipping information for accurate deliveries.
- Completed daily orders with expert picking and packing o
- Completed daily orders with expert picking and packing of shipments.
- Clean and sanitize area
- Documented all activity in the batch record
Packaging Operator
Pfizer Pharmaceutical
10.2000 - 02.2001
- Communicated effectively with team members and supervisors to address any concerns or issues that arose during daily operations.
- Labeled, recorded, and inspected packaging to prepare for shipment or storage.
- Managed multiple tasks simultaneously while meeting tight deadlines, maintaining high-quality standards in all aspects of work performed.
- Ensured proper labeling of packages according to regulatory requirements, avoiding potential fines or product recalls due to noncompliance.
- Collected samples for different products
- Clean room
- Reduced waste and improved sustainability through diligent monitoring of packaging materials usage.
- Performed packaging tasks alongside team to demonstrate proper methods according to labor plan and assigned tasks.
Education
Associate of Arts - Business Administration
Sistema Universitario Ana G Mendez - Universidad Del Turabo
Gurabo, PR05.1992
Skills
- Attention to Detail
- Customer Service
- Works Well Under Pressure
- Multitasking and Organization
- Production Documentation
- Machine Setup and Shutdown
- Modifications and Adjustments
- Communication
- Teamwork
- Multi-Tasking
- Trobleshooting
The beach, read books,
I love going to the beach listening to the waves of the sea and reading a good book
Timeline
Manufacuring Technician III
Granules Pharmaceutical
01.2023 - Current
Novartis
Manufacturing Technician II
07.2022 - 12.2022
Manufacturing Technician
Jubilant Cadista Pharmaceuticals
02.2013 - 10.2020
Manufacuring Operator
Amgen Biotechnology Pharmaceutical
09.2012 - 01.2013
Manufacturing Operator
Mylan Pharmaceuticals
05.2010 - 01.2013
Manufacturing Operator
Janssen Pharmaceuticals
04.2008 - 04.2009
Technical Packaging Lead
Warner Chilcott Pharmaceuticals
02.2001 - 03.2008
Packaging Operator
Pfizer Pharmaceutical
10.2000 - 02.2001
Associate of Arts - Business Administration
Sistema Universitario Ana G Mendez - Universidad Del Turabo
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