Richard Cruz
Delaware Water Gap,PA
Summary
Experience at Novartis, excelling in aseptic processing and cGMP compliance. Ability to enhance laboratory performance through meticulous documentation and effective problem-solving. Adept in microbiological testing and committed to delivering exceptional customer service while ensuring adherence to standard operating procedures.
Overview
6
6
years of professional experience
Work History
Cell Processing Specialist
Novartis
03.2025 - 12.2025
- Trained in performing complex aseptic manufacturing processes for personalized cell therapies in cGMP environment, adhering to SOP protocols
- Performed and passed gowning certification for aseptic processing in cleanroom environment
- Applied proper aseptic techniques including sterile gowning, handwashing, and sanitization in cleanroom environment
- Documented all manufacturing activities in detail, ensuring compliance with ALCOA+ and GDP principles
Microbiologist Technician/Department Review
SGS
01.2024 - 02.2025
- Coordinated analysis scheduling to meet completion deadlines while ensuring thorough and compliant execution of procedures and methods
- Recorded detailed activities in compliance with cGMP standards to ensure quality and regulatory adherence.
- Verified accuracy and completeness of sample information by checking lot numbers, quantities, sample conditions, and storage requirements
- Operating internal LIMS systems, including data entry, report revisions, verification of sample receipt/login, and checking pricing (quotes, purchase orders).
- Delivered top-quality customer service through prompt, accurate, and courteous responses to internal and external inquiries regarding study assignments
Study Analyst (Sterility)
Nelson Labs
09.2022 - 04.2023
- Oversaw sterility testing of medical devices and pharmaceuticals, which included scheduling, responsibility for study performance, and study organization
- Decreased quality events through consistent training and monitoring of study performance
- Identified and addressed compliance issues, safety concerns, equipment malfunctions, and process deviations.
- Managed laboratory operations, including the cleanroom, and personnel in place of manager when needed
- In charge of documentation, data entry, and reporting into the Nelson Laboratory Information System (NLIMS)
- Followed and trained analysts on laboratory tests, appropriate SOP's, and GDP/cGMP guidelines
- Facilitated daily communication with clients regarding study results, delays, progress, and sample issues
- Collaborated with QA to resolve deviations and investigate OOS/OOR issues during processes
- Acted as a scribe for 2 FDA audits, in which I gained experience in reviewing client complaints, CAPAs, investigations into OOS/OOR's, investigations into internal deviation, and root analysis-cause investigations
Laboratory Analyst
Institute for Environmental Health, IEH Laboratories
10.2019 - 08.2022
- Developed and implemented laboratory protocols and procedures to enhance testing accuracy and compliance with industry standards
- Conducted microbiology tests on raw and finished products, environmental samples, water samples, and performed quality tests following standard operating procedures (SOPs)
- Set up and conducted standardized qualitative and quantitative tests using detection methods such as PCR technology, enumeration of bacteria on agar plates, and membrane filtration to ensure reliable test results
- Identified and analyzed suspected pathogens including coli-forms, Salmonella, Staphylococcus Aureus, Escherichia Coli, and Listeria Monocytogenes to ensure product safety and quality
- Environmental swabbing and monitoring for Listeria/Salmonella for analysis
- Trained analysts how to properly perform tests in the laboratory as well as on following aseptic techniques
- Documented final results in Laboratory Information System (LIMS)
- Re-hydrated lyophilized cultures; plating and resuspension of master cultures and subcultures
Education
Bachelor of Arts - Biological Sciences, Concentration in Biotechnology
Rutgers University, School of Environmental and Biological Sciences
New Brunswick, NJ07.2018
Skills
- Aseptic processing
- cGMP compliance
- SOP compliance
- Microbiological testing
- Sample analysis
- LIS management
- Data entry management
- Problem solving
- Attention to detail
- Customer service
Timeline
Cell Processing Specialist
Novartis
03.2025 - 12.2025
Microbiologist Technician/Department Review
SGS
01.2024 - 02.2025
Study Analyst (Sterility)
Nelson Labs
09.2022 - 04.2023
Laboratory Analyst
Institute for Environmental Health, IEH Laboratories
10.2019 - 08.2022
Bachelor of Arts - Biological Sciences, Concentration in Biotechnology
Rutgers University, School of Environmental and Biological Sciences