Quality Assurance Control
Resume:
SMARANDA BROTAC
Long Beach, CA 90802
Phone: 562-***-****
*******@*****.***
PROFILE SUMMARY
Experienced Biochemist with a diverse background in drug manufacturing and laboratory processes.
Proven multi-tasking capabilities with abilities in key operational areas:
Readily able to understand department needs and priorities, while remaining focused on financial objectives.
Well versed in drug manufacturing, validation processes and quality assurance.
Detail-oriented individual experienced in all facets of pharmaceutical production and laboratory analysis.
Excellent communication skills and having the ability to work with many types of individuals.
Able to multi-task, balance numerous and diverse operations and contribute to team success.
Maintains an excellent contact base with the ability to negotiate outside services.
Able to work under pressure and easily adapt to new situations.
Self-motivated, team oriented, professional with great knowledge in laboratory analysis and drug manufacturing.
Routinely completes assigned projects on time and within financial constraints.
Assumes direct responsibility for performance of assigned teams.
Maintains high efficiency and morale in all relationships.
PROFESSIONAL EXPERIENCE
Captek International –Senior Chemist September 2010 – present
Writing, reviewing, executing validation protocols for new and existing pharmaceutical products and analytical methods. Validation and method development is done using instruments like HPLC and GC.
Reviewing and writing of validation protocols, reports and validation plans for new and existing QC test methods.
Coordinate with Quality Assurance department to implement and validate new methods and revise old methods and Sop’s.
Maintain all notebooks, assay reports, validation reports, log books and other documentation in concordance with GMP and FDA regulations.
Validation and method development is done following the FDA, ICH, and GMP, USP and Captek regulations.
Participate in internal audits.
Perform data review and calculations of all the data analyzed using instruments such as HPLC, GC, FTIR, KARL-FISCHER, AA, UV-VIS.
Initiate investigations of out of specification test results and review finding.
Initiate deviations for materials having out of specification results. Develop CAPA.
Oversee the entire calibration process of laboratory instrumentation.
Bioscreen Testing Services - Senior Chemist-Supervisor May 2007 – September 2010
Managing the evaluation and testing of finished products, raw materials and stability samples.
Perform data review for all the raw materials , final products ,stability samples and R&D samples analyzed in the laboratory in conformance with GMP’s policies, Bioscreen SOP's and FDA Regulations.
Perform data review and calculation of all the data analyzed using instruments such as IC, ICP, GC, HPLC, FTIR, Titration, Karl -Fisher and PH-meter.
Reviewing of data is done in concordance with USP, BP, EP, JP, FCC, ACS, and Bioscreen’s SOP.
Maintain all notebooks, assay reports, log books and other documentation in concordance with GMP and FDA regulations.
Oversee receiving area in doing sample release and documentation attached.
Coordinate with Quality Assurance department to implement and validate new methods and revise old methods and Sop’s.
Initiate investigations of out of specification test results and reviews findings. Develop corrective and preventive actions (CAPA).
Oversee of the entire technical operations and laboratory staff to ensure accurate and consistent testing procedures.
Answer customer questions and complains.
Review and approval of final report in timely manner.
Participate in internal audits.
Perform routine Quality Control testing of raw materials and finished products accordingly to the Sop’s and FDA regulations using instruments such as FTIR, Karl-Fisher, AA, IC, ICP, ICP-MS, HPLC and dissolution.
Heraeus Metal Processing Company - Development Chemist March 2004 – May 2007
Analyzing of laboratory samples through physical and chemical methods using instruments such as DCP, ICP, AA, IC, LECO, PH -meter and Microwave in compliance with QMS Standards.
Maintain knowledge and control of laboratory safety gear and laboratory equipment.
Maintain product files and general laboratory procedures, such as preparation of samples, homogenizing, preparation of standards, labeling of equipment and standards, as well as inventory procedures, weighing, equipment control and validation.
Creating new methods and mapping of the instruments.
Maintain general product and procedure files for laboratory process validation.
GlaxoSmithKline - Laboratory Specialist in Pharmaceutical production, 1998 – 2004
Manufacturing
Responsible for manufacturing drugs, ointments including materials preparation and technological flow supervision, through to finished product.
Prepare materials entering the warehouse by batches, in order received. Ensure no mixing of batches occurs.
Maintain manufacturing procedures in preparation of numbered batches, including weighing, homogenizing, conditioning capsules and pills, as well as blistering final product.
Supervise entire technological flow, from preparing series to finished product status, ensuring compliance with GMP and QMS standards. Verify weight of capsules, conditioning of blisters and calculate production rates utilizing efficiency diagrams.
Maintain product files for each prepared series.
Calculate series efficiency and efficiency diagrams.
Maintain product files and general laboratory procedures, such as preparation procedures, homogenizing, blistering, and cleaning. Control employee access within the factory, maintain decontamination procedures, oversee final packaging and labeling, as well as inventory procedures, weighing, machinery and equipment control.
Prepare orders for raw materials and capsules from vendors and company warehouses.
Label rooms and equipment after clean up and decontamination, maintaining signed logs.
Contribute to new product manufacturing and documentation.
Ensure machinery and equipment control as Zanasi 40.Zanasi 100, Killian, Winpak, Servac and Uhlmann.
Ensure manufacturing process validation, as well as conduct monthly and annual inventory of goods and materials.
Maintain general product and procedure files for manufacturing process validation.
Laboratory
Analyze raw materials via physical and chemical methods, such as liquid (HPLC) and gas chromatography, analytical balances, gravimetric measurements – titration and precipitation.
Analyze pills for thickness, durability and time to dissolve.
Maintain knowledge and control of laboratory safety gear and production equipment.
Quality Control
Take samples of raw materials in sequential order and according to production schedule.
Keep all delivery documentation of raw materials received, reviewed and previously analyzed. Maintain technical support for revising raw material specifications and identify technical justification needed.
Maintain vendor relationship with A.N.M. – The National Agency of Drugs, for example.
EDUCATION
MS Bio Chemistry - University of Bucharest - Bucharest, Romania – U.S. equivalency by World Education Services
BS Bio Chemistry - University of Bucharest - Bucharest, Romania
OTHER PROFICIENCIES:
Microsoft Office, including Word, Excel, Power Point, Outlook and LIMS.
Fluent language skills: English, Romanian, German and French.
Leadership training Houston Associates –2006.
HPLC course – Waters 2010
Contact this candidate