Alberto Onofre

***** * ****** **** *** Angeles CA 90047

(Cell) 323-***-**** (Email) ad2j1h@r.postjobfree.com

SUMMARY

Result analyst and Formulation/Quality Control Chemist with twenty two (22) Years of Experience

EDUCATION

Bachelor of Science, Chemistry, California State University, Los Angeles CA DEC, 2001

TRAINING AND SPECIAL SKILLS

Siemens in-house Training ● Standard Operating Procedures (SOP) ● Safety

Good Manufacturing Practices (GMP) ● Good Laboratory Practices (GLP) ● Bilingual English/Spanish

Good Documentation Practices (GDP) ● Blood Born Pathogen Training ● Microsoft Office 2007

● Handling Hazard Materials ● iMac OSX Operating System

EXPERIENCE

Nov. 2010 – present: Control/EPH Formulation Chemist and Technical Lead, Quantimetrix, Redondo Beach CA:

Responsible for leading the preparation, staging, formulation of intermediates, and bulks, equipment set-up, and gel casting procedures using approved Device Manufacturing Records (DMRs).

Facilitates training of new laboratory personnel in the formulation/casting, in-process and performance testing of products of Electrophoresis and Controls products.

Formulate regular and/or Original Equipment Manufacture (OEM) products to required specifications.

Formulate and manufacture polyacrylamide gel electrophoresis products.

Perform necessary assays and verifies all expected results.

Organize cold room, freezer, and formulation laboratory to their optimum uses.

Write, review, revise and update manufacturing documents, SOP’s, or any other necessary technical document, deviation and corrective action reports.

Assist with the writing and execution of any necessary validation protocols and reports.

Performed other tasks and duties as directed by management and supervisory personnel.

Assisted in maintaining Quantimetrix Corporation quality system

May. 2002 – Nov. 2010: Result Analyst/Technologist, National Genetics Institute (LabCorp), Los Angeles CA:

Detected infectious diseases by utilizing proprietary techniques including PCR and Southern Blotting in a cGMP environment.

Trained technicians to process samples for immunostaining, membrane scanning and result processing.

Developed, revised and validated IQ, and PQ Validation Protocols.

Collaborated with various departments to revise key Standard Operating Protocols (SOP’s), guidelines flowcharts, forms, specifications, databases, logs, and reports.

Provided training to other employees and organizes their job duties.

Processed and interpreted final results of PCR runs of different assays.

Prepared buffers, antibodies, antigen solutions and other solutions used in process.

Maintained DNA replicator, Southern Blotter, and Hybridization instruments per Standard Operation Procedures.

Jun. 2005 – Oct. 2009: Quality Control Technician III, Siemens HealthCare, Los Angeles CA:

Performed in-process and raw material testing, release and stability assays according to SOP.

Tracked and evaluated stability study data and trends to meet established specifications. Coordinated pulling and launching of stability samples according to established schedule.

Follow up with test results to ensure testing and reporting of stability samples are completed according to standard and entered into LIMS.

Reviewed stability documentation and interpretation. Initiated OOS events and investigated the root causes and impacts.

Developed and demonstrated the ability to run allergy, infectious disease assays and immuno assays across various automated IMMULITE platforms.

Performed data analysis and troubleshooting of resulting assays according to work instructions. Performed method comparison for validation and to identify issues with the manufacturing.

Conducted instrument calibration, maintenance and troubleshooting according to SOP. Performed environmental monitoring, laboratory cleaning, and maintained adequate inventory of lab supplies.

Participated in special projects and assisted lab supervisors in data review and troubleshooting. Lab compliance and product release.

Provided guidance, training, and instructions to level I, II QC Associates.

Feb. 1995 – May. 2002: Superviser, United Parcel Service, Vernon CA:

Supervisor (1999 – 2002)

Supervised 30 employees.

Provided proper training to new and current employees.

Improved productivity of areas by 30%.

Co-chair of the Health & Safety Committee.

Loader/Unloader/Sorter (1995- 1999)

Loaded feeders at a minimal rate of 550 packages per hour.

Unloaded feeder at a rate of 1,600 packages per hour.

Sorted packages at a rate of 1,600 packages per hour.

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