Management Safety

Objective: I am currently working looking for opportunity to work for your company with 16 an half years of experience and knowledge of pharmaceutical background as a manufacturing API’s associate and production,I could help grow the company and pursue a new challenging position.

Qualifications and Job Duties

16 years of experience working in GMP and SOP’S production facility. Experienced in fully gowned cleanroom operations, weighing, formulation, labeling, packaging, and cleaning according to ISO guidelines and company policies.

Familiar with equipment setup and clean procedure operation and research and development entailing changeover of products produced in small scale into large scale pharmaceutical product operations dispensing, mixing, blending, granulation, tableting, coating, and packaging.

Performed proper documentation practices in a GMP environment and compliance to controlled assay worksheets, Laboratory Information Management System (LIMS).

Provided communication to project management and manufacturing groups regarding test results. Demonstrated ability to communicate effectively to scientists, management and staff.

Familiarity with GMP and PPE standards of practice. Demonstrated safe work and safe lab practices including personal protective equipment, knowledge of chemical industry safety practices, safe chemical storage, and interpretation of chemical safety data sheets (SDS), shipment practices, and standards guidelines.

Technical support for team of development scientists.

Perform all duties involving validation and statistical analysis of new experimental, change control and ANDA drugs.

Have input on the development of new cleaning procedures and equipment.

Perform all trials and analytical testing of small scale production per formulation protocol proficient on equipment and process of finished dosage, involving tableting and coating.

Make adjustment to the formula and equipment necessary during the development process.

Weigh small and big scale batches of API’S.

Have 7 years of a team leader.

Experienced and trouble shooting, skill with Dispensing (weight out products by following batch records) and compound mixing.

Chemicals mixer (measure and weigh for etching process).

Measure lenses.

Neutralize chemicals using sodium Bicarbonate until it read 7 on pH scale.

Use pH scale is a measure of the activity of hydrogen (or hydroxide) ions.

Experience

RESEARCH ELECTRO-OPTICS (REO) APRIL 2018-CURRENT

DRY CLEANER OWNER 2016-MARCH 2018

Sandoz Inc. Production Technician ATO III

JUNE 1999-FEBRUARY 2016

Summary of Qualifications

Supported regulatory affairs by assembling quality assurance methodology, data, protocols, and validation reports for the purpose of filing ANDA’s, and other FDA required annual submissions.

Help SOPs, equipment qualifications, new method training and transfer, performing laboratory investigations, reviewing notebooks and raw data and complying with GMPs, and general safety guidelines.

Pre-formulation and stability R&D pharmaceutical testing experience in dissolution, product purity, content uniformity, related compounds, blend uniformity, residual solvents.

Mastered skills needed for large-scale bulk production.

Performed final review for documentation error on all equipment log and batch records

Ensure that usage of chemicals is recorded in warehouse inventory system.

Performed equipment cleaning according to FDA standards.

Work well independently and on a team.

Use SAP tracking program to locate parts and inventory in warehouse.

Always willing to learn and understand the importance of exact documentation.

Always compliant to current health, safety, and environment standards.

Assembled precision mechanical components in clean room environment using engineering drawing, written procedure and standard work specification.

Tested and repaired circuits and PC boards with soldering.

Measured products with different tools including calipers, micrometer and CMM machine.

Technical coordinator providing technical and product support, project management, process analysis, trouble shooting, consulting and group training.

Storage Technology Corporation

CNC Machinist III March 1992- June 1999

Operated CNC machining operations to cut, trim, and slot wafers with actuators and flex circuits to create magnetic recording heads that are used for tape drives.

Utilized machines for lapping and grinding the modules in order to create contours.

Assembled and wired tape reel.

Completed pole, resistance, and failure tests as well as contamination inspections on NGD and servo writer.

Education

Graduated from westminster High School

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