Production Lead Dental Assistant

Marisela Sainz

*** * ***** **. # **

Tustin, CA *2780

Email: ******@*****.***

Mobile: 714-***-****

OBJECTIVE: Seeking a challenging position in Pharmaceutical and Medical Device Manufacturing/Production with a company where my skills and experience can be effectively utilized and where professional advancement can be achieved.

EMPLOYMENT:

2008 – 2021 Glaukos Corporation- Production Lead

Utilize Microscopes for inspection of eye stents, and sub-assemblies components. Etching components in a Lab utilizing IPA, caustic acids per (WI) and MSDS guidelines. Weighing of wet and dry chemicals utilizing balance scales. Wash components prior to building. Responsible for assembling, testing, inspecting, sealing, labeling and packaging per DHR, GMPs, GDPs and SOPs. Perform data input prior to DHR released. Keep track of inventory control. Ensuring all clean room equipment is up to date and calibrated. Trained in Oracle. Instructing, overseeing and training the production team and to insure they are in compliance. Verifying accuracy of printing labels and inserts Utilizing the Zebra printer, make ing adjustments and modifications. Help out other departments as needed, collaborate with QC department to resolve issues such as verification and line clearances. Work with engineers pilot ops,implementing new products . Assist in assembling, testing, protocol, utilizing tools and equipment performing activities such as Pharma following GMPs and WI. Basic troubleshooting. 2006 – 2007 ISOTIS OrthoBiologics- Production Tech Formulation of Bone graft, performing sterilization technique following GMP, and SOPs procedures. Bulk mixing under a bio-safety (LFH) cabinet filling syringes from 1cc to 10cc maintaining aseptic. Other tasks: extraction, filtration, Bone splitting in pouches, Sealing, labeling and packaging 100% visual inspection. General daily cleaning, re-stocking supplies and other duties assigned. 2004 – 2006 Cosmedex Science- Quality Control

small bulks of products collected from in coming receiving the warehouse for testing prior to releasing such as shampoos, conditioners, creams, and lotions, pH testing. Adjustments on viscosity and color check. Create COA per product release. Data entry, light customer service. Collect samples from production for testing and verification.

2001 – 2004 Teva Pharmaceuticals- Compounder I

Responsibilities: compounding, such as weighing, mixing wet chemicals, compliance with WI and adherence with GDP, GMPs. pH conductivity and UV adjustments. Cleaning delivery lines, maintaining documentation, of Batch records, logbooks; formulating cleaning solutions for cleaning hoses, tanks. And microfluidizers . Autoclave components prior to filling following safety procedures, and SOP’s. Test conductivity for WFI. Tag,weighing products accordingly and stored. Help other departments. 1999 – 2001 Bio-Rad Laboratories- Manufacturing Associate Formulation responsibilities : weigh wet chemicals. pH conductivity, process Human plasma and bodily fluids in small and large bulks utilizing large scales. Charcoal stripping and Dialyses. Performed filling, capping, catching, labeling and packaging. House keeping and maintaining a clean area at all times. Work well with others. Auto calving components. Storing products (controls) in freezers at -20/40 degree Fahrenheit. Log and document paper work (BRs). Report any issues to the supervisor. Light data entry. 1997 – 1999 Baxter- Quality Control

Inspected and approved Heart valves,aortic stent threading, performing automated float machine for testing purposes. documenting (WI). Maintain appropriate maintenance and log books. Perform calibration and alignment checks. Report any discrepancies or issues that arise. Collaborate with production team. Maintain GMPs, GDP.

1990 – 1997 Medtronic Heart Valve Division- Dissect Technician Harvested department duties: Dissected hearts, shaving down the large Aortic valve prior to mounting

(sew) dept. Utilized surgical instruments, ordered and maintained aseptic supplies for production and quality control department. Restocking inventory. Help out in Quality department to Inspected and measured in-process raw materials AQL lot size sample utilizing calipers, micrometers, gauges, and stored away in quarantine. Worked in central supply dept. wrapped instruments, foiled beakers and carboys for a large automative Autoclave.

EDUCATION: Regional Occupational Program

Certificate in Medical Back Office/ Dental Assistant Program, 2004. REFERENCES: Available upon request

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