Training Management

Priscila Lozada

Lakeland, FL

**********@*******.*** - 787-***-****

WORK EXPERIENCE

Filling and Packaging Technician

Becton & Dickinson Biosciences - Cayey, P.R., US - September 2010 to December 2012

Manufacturing Department

• Coordinate daily/weekly/monthly departmental production objectives.

• Independently organize individual schedules to meet department goals.

• Execute Filling & Packaging Process by scheduling, filling, labeling and bagging vials for purified and

conjugated materials.

• Perform line clearance for QA approval.

• Execute validation protocols.

• Generate requisitions and replenish departmental packaging supplies and materials management function

including storing, retrieving and standing supplies/materials as required.

• Process Packaging data in SAP system.

• Equipment used in process EDOS 5222, biohit pipettes, Analytical balance, Duplo folding machine, Auto

bagging Machine, Zebra Printer, Stir plate, TA4, barcode scanner, Autofiller Machine, CVC Labeler, peristaltic

pump, capper machine, torque tester, Chatillon, and Domino Printer.

• Monitor chart recorder, room pressure and humidity.

• Review of SOP, Batch Records, Forms and Engineering Change Orders.

• Implementing metrics for the Packaging Department.

• Conducts 5S, Safety and ACES audits.

• Support and conduct investigations.

Documentation Specialist

Fire, Health and Safety Consultants - July 2009 to December 2012

Prepare and process training materials for Hazwoper, Safety, Fire prevention and extinction.

• Create all types of documents for registrations and certifications.

• Create presentations and proposals for the training of the different companies to be given by our trainers.

• Create many documents and presentations using different programs for example: Power Point, windows XP,

Vista, Excel and Access.

• Validated emergency protocols.

• Prepared all documentation and estimates according to costumer's necessities.

Product Operator

St. Jude Medical LLC - November 2009 to April 2010

Neuromoudulation Production Area

• Worked in the neuromodulation production area.

• Realized kit Verfications.

• Maintained the materials inventory for the production process.

• Prepared and checked all documentation about the components before beginning the process.

• Created the travel and work orders.

• Inspected the pieces before beginning the work process.

• Inspected all the materials to assure they had the parts number, batch number and the expiration dates.

• Prepared the bottles of alcohol with 70 - 99% to clean and sterilize the production

• lines and the products.

• Generated cleaning and laser engraving to the product.

• Certified in gowning and "clean rooms".

Investigation's Student

University of Puerto Rico Humacao Campus - Humacao, Puerto Rico, US - January 2004 to December

2008

Sub graduated investigation

• Performed investigations on specific type of bacteria, known as "salmonella".

• Executed different test that were mandated. Analyzed the many types of cultures obtained using standard

aseptic (germ free) techniques and the knowledge of GMP - GLP.

• Documented the findings using charts, programs on the computer, my analysis and provided the end product

result to the supervisor in charge of the bacteria via written format.

• Used different types of "Agar Media" for example: McConkey, R2A, SMA, LMA, TSA and Mendo to name

a few.

EDUCATION

Master Degree in Marketing

Turabo University - Puerto Rico

2013 to 2015

B.S. in Microbiology

University of Puerto Rico - Humacao, Puerto Rico, US

May 2009

ADDITIONAL INFORMATION

More than three years of experience in medical devices for the quality department and more than two years

of experience in biosciences industry for manufacturing department making:

• Test

• Documentation and troubleshooting

• Validation/Qualification

• Inspection

• Trainer for new employees

• Preventive maintenance

• Filling & Packaging Process

• Audits

Core Competencies

• Knowledge in the management of laboratory instruments and separation techniques.

• Knowledge in ISO, OSHA and FDA regulations.

• Knowledge in 5S, Kaizen and ACES programs.

• Knowledge on sampling plan ANSI

• Experience in microbiology laboratory techniques.

• Experience in validation, qualifications, amendments, IQ, PQ, OQ.

• Experience with the review of documents like: SOP, Batch Records, NCR's and ECO's.

• Management in computers: Lotus Notes, wwLIMS, SAP, QDMS, Documentum, AMM, CAPA, Word, Excel,

Power Point, and ECHIP.

• Fully Bilingual: Spanish/English

• Dominion of different techniques used in molecular sciences; such as: PCR, DNA sequencing and

electrophoresis.

• Expertise on the use of: GMP/GML. ISO, USP, SOP, EP, CAPA, QSR and non-conformance protocols.

• Training and development of numerous filtration techniques.

• Training of Microscope, Analytical Balance, Autoclave, R2S, SMA and SAS air sampling equipment.

• Training in cleaning room and incoming area.

• Comfortable working has a team and or with minimal supervision.

• Trained on how to document and illustrate the different information observed in the scientific laboratory test.

• Expertise in pipette, scale and other packaging equipment.

• Expertise in creating different presentations.

• Ability to follow general instructions on routine tasks and detailed instructions on new tasks.

• Trainings in Hazwoper and First Aid complete.

Contact this candidate