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Chemical Engineering Manufacturing

Location:
Hialeah, FL
Salary:
60k
Posted:
July 30, 2016

Contact this candidate

Resume:

Mirtha Noa Blanco

Hialeah Gardens, FL, *****

305-***-****

acvyag@r.postjobfree.com

Professional Profile

Chemical Engineer with more than twenty years of experience in chemical and pharmaceutical industry. Highly motivated achiever with a strong sense of responsibility, commitment, and professionalism. Enthusiastic, fast learner, thinker, strategist, communicator, oriented, loyal, strong team player, continuous improver, strong values, natural leader, problem solver. Education

Master of Science in Chemical Engineering from Moscow University of Chemical Engineering

(D.I.Mendeleiev), Russia. Graduated in June 1989.

Professional Experience

September 2015-Present – QA Document Control Specialist- Pure Source, Inc. Doral, FL

Responsible for overall coordination of controlled documentation within the company

Performs QA documents control function, including document login, tracking, processing, approval, distributing and archiving.

Coordinates the revision, review, and approval of SOPs and other documents.

Responsible for SOP biennial update.

Organizes and ensures accurate and reliable filing systems for all paper-bases GMP documents.

Selects, evaluates, and implements electronic document processing and archiving systems.

Coordinates with user maintaining up-to-date manufacturing and testing documentation for Pure Source Inc. manufactured products.

Maintains in house training programs including training matrix, training files, and annual audit of training files.

Maintains change control and deviation processes for internal SOPs, master batch records, specifications, test methods, validation protocols/reports and technical protocols.

August 2014 -2015 - International Registration Specialist - Arnet Pharmaceutical Corp. Davie, FL

Prepare and review pharma registration dossiers for regulatory compliance in common technical document (CTD) and ACTD format or as per country specific requirement for domestic and international customers.

Write and review New Drug Application (NDA)/ Marketing Authorization Application

(MAA). Analyze product formulas and coordinate with in-house formulator to ensure Active Pharmaceutical Ingredients (API) and excipients are within country specific guidelines.

Work with change control, revision control.

Coordinate the preparation and Legalization/Apostilles of FDA certificates, Free Sale Certificates (FSC), Good Manufacturing Practices (GMP) and Declarations of Conformity for international product registrations.

Prepare and edit Summary of Product Characteristics (SPC), Standard Operating Procedures (SOP), Standing Testing Procedures (STP) and Certificate of Analysis

(Analytical Report).

Write and review Quali-Quantitative Formula, Product Specification, Specification Certificates and Composition Certificates. Review and guide OTC product label preparation for USFDA submission.

Coordinate with multi-disciplinary team members (Quality Assurance, Quality Control, Formulation & Development departments) as applicable. Ensure the regulatory submissions are adequate and error free, with minimum open issues.

Manage support activities including maintenance of license documents and the provision of supporting documentation for global regulatory affairs as required. Monitor the process of regulatory submissions and ensuring registration approvals are granted without undue delay. Respond to technical inquires or complaints from international and domestic customers pertaining to regulatory affairs and product registration. Dec 2012-2014 QC Chemist I, Sentry Manufacturing, Miami Lakes, Fl.

Responsibilities include the testing of physical and chemical characteristics of nutraceutical products in raw materials, intermediates, and finished products.

Performing Assay by titrations, Karl Fisher Titrations, LOD, FTIR, UV-Vis, Friability, Hardness and Disintegration testing, Mobile Phase and Standard Preparations for HPLC following all company standard operating procedures and GMP and FDA regulations.

Inventory responsibilities include keeping accurate records of supplies, solvents, reagents and laboratory equipment, which includes managing expiration dates and receiving laboratory products.

Daily responsibilities include calibration of analytical balances and pH-meter, and media preparation.

Routine tasks include keeping the waste room clean and orderly, properly labeling waste tanks upon receipt and neutralization of acids for proper disposal. 2008-2012 Documentation Specialist, Sentry Manufacturing, Miami Lakes, Fl.

Responsible for data entry of all internal and external analytical laboratory results for all company products using approved Certificates of Analysis templates.

Responsibilities included document review to ensure accuracy, secure storage, efficient access to technical documentation for review or updating and maintenance of Documentation files/databases to ensure data accuracy.

Served as principle documentation control for all laboratory records, including electronic records as generated.

Review and approve manufacturing, and packaging batch records. Release manufacturing and packaging batch records. Keep tracking of batch record errors.

Update changes to documents by typing changes to an existing SOP, form, or any controlled document. Review for accuracy, distribute and track for approval routing.

Update the data base index and corresponding master files with the new approved change and remove the old document from the file. Open change control to update SOP’s associated with document control procedures.

Audit the masters for appropriate revision as well as the binders and electronic drive.

Communicate any questions on documents to lab manager. 2001-2008 Chemical Engineer/Technologist, Polyplast Industrial Plastics, La Habana, Cuba

Prepared and mixed materials and pigments used in the manufacturing of the molding department.

Performed technological adjustments, testing, maintenance, and stabilization of the manufacturing equipment.

Wrote and revised the specifications for finished product.

Managed Calibration Department, interacted with all affected personnel, Quality Assurance, Manufacturing, and Quality Control, in the execution of work orders.

Controlled the entire production process as well as the parameters of the different machines during manufacture of various plastic articles.

1994-2000 Chemist, Polyplast Industrial Plastics, La Habana, Cuba.

Performed complex testing of raw materials and finished products.

Maintenance and calibration of analytical instruments, prepares standard and sample solutions, and maintains appropriate records.

Operated general analytical instruments during routine testing, performs wets Chemistry tests.

Performed analysis on intermediate and finished products.

Maintained appropriate documentation (records and lab notebooks) as required by SOP's. 1989-1993 QA, Line Inspector, Polyplast Industrial Plastics, La Habana, Cuba

Responsibilities included management of the production lines and the quality of finished products.

Performed technological testing adjustments, mounting, and stabilization of equipment, and general plant supervision.

Responsibilities included supervising the production line, included pharmacy, manufacturing and packaging. Reviewed data generated from production areas and records. Additional Skills

Excellent attention to detail. Strong analytical skills.

Experienced working in variety of plastics process (extrusion, injection, hollow body blow, blown film, etc.)

Experienced in general wet chemistry, and in the use of pH meters, analytical balances

(calibration), etc.

IR (Genesis II), UV-vis (Perkin Elmer), Titrations, Friability, Hardness and Disintegration Testers, Karl Fisher Titrator.

Working knowledge of Microsoft office, Adobe Acrobat and electronic document management systems (Imaging 101, J.D.E, Virtual, Xerox, MAS 200, PDF Studio)

Working knowledge of current Good Manufacturing Practices, Good Documentation Practices.

Knowledges of FDA, and USP guidelines.

Ability to work with a wide variety of colleagues within R&D and from other departments as well as different levels of Management. Skilled at multitasking.

Ability to work under pressure to meet deadlines.

Strong critical thinking, communication, and problem solving skills. Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.

Languages

English

Spanish

Russian



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