Contractor (PEP) R&D ASSOC SCIENTIST Resume

SUMMARY

Industrial Engineer with strong experience advanced product quality planning (AQPP). Experience in validation protocols (IQ/OQ/PQ/CSV), data analysis, quality and process reports, regulatory compliance from defect detection & rejection and documentation.
Detail - oriented professional with lean six sigma, 5-s, value stream mapping, scheduling, process improvement, and continuous improvement efforts, layouts, data analysis, data trending analysis, pivot tables, run reports and data collection.
Skill in quality assurance and manufacturing engineer experience are an application of lean six sigma tools field research and professional work experience in the pharmaceutical and medical devices, cGMP'S regulations and process optimization and procedures.

PROFESSIONAL EXPERIENCE

Confidential

Contractor (PEP) R&D ASSOC SCIENTIST

Responsibilities:

Arrange for system maintenance for FSS including data cleanup and maintenance of reference information.
Perform system testing for new software releases for upgrades and enhancements.
Creating and maintain queries against system data.
Notify customer support for documentation applications:
Simplify resolution of documentation issues
Ensure document consistency.
Manage formula life cycle, which involves updating overall formula status, site-specific status, and start/stop ship dates
Delivery for available product development and project support.
Exhibit business maturity in handling confidential information.

Confidential

Responsibilities:

Reinforced the Intelliport Department with built maintained and calibrated testing equipment and Syringe concern solving a problem to recognize prospects for cost reduction, inventory reduction, and quality improvement while improving employee safety.
Coordinate the making detailed plans to accomplish goals and directing the integration of technical activities laboratory and assisted with the preparation of testing Confidential product for design verification and
Analyzed and interpreted testing results to result in design issues. Remained updated on all current electrical safety measures and modified prototypes syringe label assemblies and systems.
Trainee employees; assign, evaluate their work and administer the development and maintenance of control competence.
Develop and implement policies, standard and procedures for the engineering and technical work performed in the department, service, laboratory or firm.

Confidential

Quality Assurances

Responsibilities:

Supported the Quality Department with Material Report Review (MRR) and manufacturing investigations for medical devices according to company quality policies. Reviewed inspection criteria Device History Record (DHR): inspection methods, alignment to procedures to meet quality standards.
Investigate product complaints and management activities required to assure the timely implementation and document corrective action. Monitored inspection test results and initiate corrective actions to maintain acceptable levels quality.
Responsible for investigating and monitoring customer complaints with regard to product quality. Documenting the investigations following the guidelines established in the procedures.
Design and modify controlled documents in accordance with FDA 21 CFR Part 820/210/211 regarding the manufacturing of medical devices. Train staff concerned for the proper execution of the changes.

Confidential

Product Robustness Scientist

Responsibilities:

Analyze the data of control charts, normal probabilities plot and give recommendations based on statisticaldata. Perform process verification to verify if the product remains withincontrolparameters:
Evaluating data from batch records
Monitoring batch record
Compliance targets.
Define and/or perform Design of Experiments, Confirmation, and Revalidations associated with process changes, modifications to existing equipment.
Maintained and updated the Batch Manufacturing Records and documentation of a log, calibration records, temperature and humidity records. Retrieve and manage Product Robustness data to ensure Critical Quality Attributes (CQA) and Key Process Parameter (KPP) is within process control limits.
Provide Quality Systems, according to the requirements established for the packing area and the requirements of the Industry and using implements for continuous improvement and reduce defects in products, processes or eliminate the causes that generate it.

Confidential

Process Engineer

Responsibilities:

Collaborated in reviewing floor layout of Cell Operating System (COS) in order to fit a news pace saving design products lines. The prepared specifications are layout systems and to graphical maps to ensure that installation and operations conformed to standards and customer requirements.
Write working process Failure Mode Effect Analysis (FMEA) and provided technical support of Process Operation Descriptions (POD) and Standard Operating Procedure (SOP) and ISO 900.