Alexander Garcia Email & Phone Number

Chicago, Il, Us

- Mentored the professional development for a team of 15+ project engineers.- Facilitated project updates, timelines, purchase orders, and feedback reconciliation between project engineers and client managers.

Greater Chicago Area

VALIDATION ENGINEER- Developed Qualification Documentation for successful implementation of new Pharmaceutical Manufacturing Equipment for various companies while staying in compliance and adhering to GxP guidelines. (i.e. URS, Risk Assessments, Design Qualification, Installation/Operational/ Performance Qualifications, SOPs). Relevant equipment: vial labeler, tray packers, banders, cannabis extractor.- Demonstrated knowledge of successful FAT, SAT, Installation Qualification, Operational Qualification, and Performance Qualification Validation activities for new Pharmaceutical Manufacturing Equipment. Relevant equipment: vial labeler, tray packers, banders, capping/crimping equipment.DEVIATION/CAPA PROFESSIONAL- Wrote investigation/deviation/non-conformance reports for all components of the pharmaceutical manufacturing process (component prep, formulation, filling, packaging, microbiology, chemistry, plant maintenance, engineering, customer complaints, etc). Each report assessed initial impact to critical systems/product/equipment, identified root causes throughout root cause analysis (RCA) tools, and implemented corrective actions/preventive actions (CAPA) to eliminate or reduce recurrence of events.-Trained multiple investigation writers on how to perform and document the entire investigation process.- Oversaw and implemented an improved CAPA program for a large client. Provided new procedures, guidance, interpretation, support, and training to various departments to increase compliance with investigative actions/reports, CAPAs, and general overdue records.COMPLIANCE DOCUMENTATION SPECIALIST:- Created and revised various standard operating procedures (SOP) relating to equipment operations/maintenance, company quality manuals, manufacturing batch records, and other document binders required to comply with regulatory requirements (i.e., recall procedure, storage/warehousing procedure, investigation procedure, product specification procedures, etc.)

Hanover Park, Illinois

- Managed a project to perform preventative maintenance, repairs, and upgrades to software for infusion pumps while achieving 100% customer satisfaction.- Served as the subject matter expert on multiple infusion and enteral pumps- Trained over 12 BMET’s on proper operation of equipment which included repairs, calibration, quality, and troubleshooting- Used Onetrack Software to track customer issues, identify root causes, perform corrective action, and proper documentation per ISO 13485 standards- (Original company was named Medical Specialties Distributors prior to McKesson buyout)

Chicago

- Tutored students in algebra, biology, calculus, electrical circuits, physics, and statistics. - Had a consistent set of students who continued to come back to my tutoring sessions throughout the school year,

Greater Chicago Area

- Canvassed various neighborhoods to conduct research in the form of in-person interviews pertaining to the UIC Social Sciences department.- Required adapt social skills to persuade strangers into performing the research interview.- Facilitated the research interviews to ensure discussion stayed relevant in a timely manner.

Greater Chicago Area

- Worked in the electronics department where I would educate customers about any thing they were interested in. Suggested items to customers based on their needs and their budgets in a friendly manner.

Greater Chicago Area

- Conducted countless transactions with various clients for a Fortune 500 company.- Processed returns for various clients and assessed quality of returns to ensure correct product return pathway.

Bachelor’S Degree, Biomedical/Medical Engineering

Activities and Societies: Rock Climbing Club, Biomedical Engineering Society Majored in biomedical engineering with a specialization.

Education record