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Quality Control Assurance

Location:
Great Neck, NY
Posted:
August 26, 2012

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Resume:

MIRYAM G RIVERA

** **** **** ***** *** *A

GREAT NECK, NY 11021

wtfbtb@r.postjobfree.com

EXPERIENCE: US Nonwovens Corp. Brentwood, New York 03/12-Present

Laboratory Manager, Quality Control Department

•Ensures that day to day testing and product releases from the Analytical Laboratory are being done in a timely manner.

•Revises/creates specifications for test methods and vendor specifications to confirm compliance to FDA, EPA regulations and product characteristics. If non-conformances are found investigations are created to find root causes and assigns corrective actions preventive actions (CAPAs) to limit potential recurrences.

•Trains and maintains training records for all employees within the department to confirm that all procedures, SOPs and company policies are being followed.

•Ensures proper use of instrumentation and validity of data by being proficient in laboratory data interpretation.

•Leads and assists in the implementation of Visual Quality software within the company.

•Heavily involved with the quality assurance department to ensure lot coding, documentation, presentation and product quality are improved constantly.

•Assist the International Sales Department with regulations and product approvals in Spanish speaking countries.

•Represents company values and products to internal and external customers during audits.

FOUGERA PHARMACEUTICALS INC., Melville, New York 06/07 – 6/12

Sr. Chemist, Analytical Services Department

•Proposed and assisted with the implementation of safer ways to collect HPLC waste. Making the laboratory a more health and safety oriented environment for its employees.

•Suggested and implemented a more efficient way of documenting daily balance calibrations to save time, limit human errors and be compliant.

•Offered a new way of storing data within Empower to reduce paper, save time and be more compliant with FDA requirements of documentation.

•Performs advanced analyses such as degradation, assay, homogeneity and related substances tests for topical steroids in the form of gels, creams, ointments, suspensions and many others.

•Troubleshoots and performs repairs on HPLC systems.

•Assists supervisor with writing of CAPAs, investigations and test procedures.

•Revise and edit SOPs, procedures and specifications to improve and minimize discrepancies and insures compliance with FDA and cGMP requirements.

•Labels, packages and handles hazardous materials on a daily basis in accordance with local, state and federal regulations.

•Informs management quickly and proficiently of any circumstances that may delay a product release.

•Proficient in the use of Empower software and has good integration techniques.

•Provides training for new employees on how to properly and competently follow all procedures such as report methods, sample preparation and HPLC instrument set up.

Watson Pharmaceuticals, Copiague, New York 08/06 – 06/07

Chemist I, Quality Control Department

•Performed Assay, Content Uniformity, Chromatography Purity and all other necessary tests for Nicotine gum finished product and stabilities in a timely manner.

•Performed raw material testing to approve quality of raw materials.

•Participated in scouting of new product constituents and new equipment.

•Performed daily weight checks for all balances to ensure adequate instrument performance.

•BBI team secretary responsible of the weekly minutes and entry of daily observation data.

•Represented the QC Laboratory in scheduling meetings to inform other departments of the status on new lots and raw materials that were sent to the laboratory for testing and release.

EDUCATION: Keller School of Management, Rego Park, New York 05/11 – 12/11

MBA (Not conferred)

•Enrolled in management courses to acquire critical thinking skills, leadership skills and management tools to become a successful manager.

SUNY at Stony Brook, Stony Brook, New York 09/03 –05/06

Bachelor of Science, Chemistry Conferred May, 2006

Teacher Assistant for Organic Chemistry Lab. under Dr. Chen 09/05 – 12/05

oTaught good laboratory skills and laboratory procedures to students.

oFiled and kept record of students work and progress.

oAssigned students final grades.

Organic Chemist under Prof. Francis Johnson 01/04 –09/05

oRepresented the school’s Chemistry Department at the

URECA Chemistry Research Symposium Summer 2005

o Received the New York Research Foundation Grant Summer 2004

o Acquired skills needed to synthesize, separate and identify chemical compounds with minimum assistance.

LABORATORY • Thin-Layer Chromatography (TLC) • Empower Software

INSTRUMENTS/ • Infrared Spectroscopy (IR) • Nova Manage Software

SKILLS: • UV-Vis Spectrophotometer • Documentum Software

• Gas Chromatography (GC) • cGMPs and cGLPs

• MS Office (Word, Excel & Power Point) • Problem solver and quick learner

• Laboratory Information Management Systems (LIMS)

• Ultra Performance Liquid Chromatography (UPLC)

• High Performance Liquid Chromatography (HPLC)

LANGUAGES:Fluent in both Spanish and English. Able to write and review technical Spanish if needed.



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