Quality Control Laboratory

Karen Del Valle López

***** **** ***** ******* ***. 1021

Austin, TX 78729

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

SUMMARY OF QUALIFICATIONS

Chemist with over 14 years of experience within the Pharmaceutical industry. Experience in laboratory analysis, such as Physical, Dissolution, Assay, Impurities, TiO2 Identification, Granulation, Weight Variation, Uniformity of Mass, Content Uniformity, Identification, Water Content (Moisture), Disintegration, Loss on Drying (LOD) and Cleaning (Residual Trace in Swab Samples, Detergent). Knowledge in different laboratory equipment, such as HPLC, UPLC, UV/VIS, Dissolution Bath Manual & Automatic (Apparatus 1 & 2), pH – meter, Analytical Balance, Microbalance, Top Load Balance, Karl Fischer, Muffle, Automatic Pipette and Centrifuge. Good knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), SOP’s, Instrument Operational Procedures (IOP’s), MSDS and USP. Computer: Windows 2000/Vista/7/8, Word, Excel, Power Point, Outlook, Internet Explorer, LIMS, Core LIMS, LIMS LabWare, PeakPro, Empower 2, Empower 3, Dreamweaver CS5, Fireworks CS5, Flash CS5, Photoshop CS5. Languages: Fully Spanish and Intermediate English.

PROFESSIONAL EXPERIENCE

MYLAN, Caguas, PR 2014-2017

Chemist

Execute Cleaning Validation test for Manufacturing and Packaging area.

Login and receive samples for analysis.

Review of data and deliver results.

Performed analysis according written procedures using equipment and instruments provided.

Recorded data in an orderly manner following laboratory rules and SOP’s calculates results as required, compared results with specifications and seek further direction when are not met.

Entered tests results in the Data Base and informed supervisor if any discrepancy is found.

Performed any other duties as assigned by supervisor.

Laboratory housekeeping when needed.

NEOLPHARMA, Caguas, PR

Formerly Pfizer

2013-2014

2002-2013

Laboratory Technologist

Performed analysis according written procedures using equipment and instruments provided.

Worked with instruments of advanced and/or sophisticated nature under limited supervision and performed some troubleshooting work.

Prepared laboratory solutions according to standard formulas to be used in assays and some instruments if so required by procedures.

Recorded data in an orderly manner following laboratory rules and SOP’s calculates results as required, compared results with specifications and seek further direction when are not met.

Assisted in training new technicians in specific task.

Assisted in or carried out work of an experimental nature while under limited supervision.

Entered tests results in the Data Base and informed supervisor if any discrepancy is found.

Kept records and files up to date and assures that information is available at all times.

Performed any other duties as assigned by supervisor.

Laboratory housekeeping when needed.

Selected Accomplishments:

Performed and executed instrument qualification, operational qualification and procedure qualification to implement a chromatography system simultaneous between Plants and successfully provided training for laboratory personnel.

Awarded for perfect assistance during all the years working for Pfizer.

EDUCATION & CERTIFICATIONS

Universidad del Turabo, Gurabo, PR

BS in Chemistry

Digitever

Certificate in Web Design

Certified as Train the Trainer

Laboratory Technician, Laboratory Technologist, Laboratory Analyst, Chemist, QC, Lab, Quality Control

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