SUMMARY:

• Quality Tools
• Quality System Regulations (QSR) 21CFR§820
• Correct and Preventive Action
• Quality Control ISO 13485
• Complaint Handling
• Quality Assurance ISO 9001
• Production and Process Controls
• Quality Systems ISO14971
• Process Validation
• Test Method Verification/Validation
• Six Sigma
• Equipment and Facility Controls Document
• Records & Change Controls

TECHNICAL SKILLS:

Software: EtQ, SPSS Statistical software, Linux, SAS, Simulink, SQL, Matlab, R, MS office Suite, Access, HTML, Minitab, LabView, 3D CAD, MathCad, ChemCad, AutoCad, SolidWorks, Product Design, Cognos BI, Enovia, EtQ, Tableau, Prism and Premier design.

WORK EXPERIENCE:

Confidential

Quality Engineer

Responsibilities:

• CAPA SME & Process Validation: Conducted CAPA Investigations, identified Root Cause(s), Corrective Action Plan, Preventive Action Plan, Reviewed Risk Assessment, Implementation, Approvals, and VoE for CAPAs needing remediation.
• Lead CAPA Process Management: by leading the various CAPA Phases and documentation, removed roadblocks, and CAPA Closure.
• Conducted CAPA Investigations and CAPA compliance by monitoring, reviewing and analyzing the various CAPA Phase activities to move the CAPA to VoE.
• Reviewed CAPAs for closure by ensuring the CAPA investigations proceeded at the defined pace, ensured all action items were assigned, and completed, and that the final due date for CAPA implementation was met.
• Kept CAPA Management apprised of the progress of the CAPA and identified roadblocks. Also, apprised CAPA Management, and the product data, and trending utilizing Validation Protocols, and Post Marketing Surveillance Analytics, as CAPA evidence, and compliance to the QSR.
• Supported management during external inspections by participating in these inspections as required, and assisted with supporting documentation with FDA inspections on regulatory requirements and quality processes.
• Assisted in the interaction with regulatory agencies regarding medical device reporting, vigilance reporting and product recalls.
• Interfaced with FDA, MHRA, Bfarm and other regulators, and responded to and managed responses to regulatory inquiries.
• Supported external audit preparation, assessment of quality plans, responses to internal and external audit observations.
• Technical Investigations - Root cause Analysis, CAPA resolutions, dFMEA, GAP analysis, DHR and DHF remediation.
• Monitored CAPA effectiveness and audit trending of quality data streams data and trending amongst various departments.
• Developed test method protocols and test method validation protocols to support complaint trending
• Executed test method validations, inspection procedures for the assigned product
• Reviewed, identified and remediated CAPAs for proper content (problem investigation, risk assessment, root cause, MDR, MDV reports, action plans, Device history records).
• Reviewed quality system gaps, redundancies and errors with CAPA owners about the product or process issues.
• Remediated over 4000 records for FDA observation quality system CAPA.
• Performed test methodvalidations as per FDA regulations and ensure product compliance
• Revised Corrective and Preventative Action and remediated reports on backlog CAPA complaints.
• Analyzed non-conformances, assisted CAPA team to determine appropriate containment, problem statements, root causes and identified effective resolutions.
• Processed customer complaints according to the CAPA Remediation and FDA Observations.
• Lead technical investigations to identify root causes and develop and implement Corrective and preventive actions.
• Performed risk management and risk analysis activities.
• Directed the CAPA remediation efforts with the CAPA Owners.
• Lead internal audit of seven of the 483 observation quality system remediation CAPAs as necessary.
• Performed trend analysis of products and system data.
• Provided validation strategies and testing guidance for corrective actions and preventative actions across multiple sites.
• Investigated product failures of components for root cause.
• Ensured that CAPA records were complete.
• Facilitated mentoring /coaching engineering personnel.
• Reviewed the quality performance of the assigned suppliers via quality reports, and quality audits.
• Technical writing - regulatory reports, technical justifications and SOP reviews.
• Managed in house and supplier customer complaints.
• Provided technical guidance for supplier improvement activities.
• Provided technical expertise and assistance in handling complaints to comply with the current FDA and International reporting regulations.
• Responsible for complaint final assessments and approvals.
• Created technical reports, MDR and MDV submissions.
• Responsible for reporting, documenting and tracking metrics and other data to assess performance of the quality system compliance project.
• Completed investigations which include execution or coordination of product returns and subsequent evaluations.
• Implemented and Approved VoEs.
• Determined reportability of complaints.

Confidential

USF Technology Transfer Intern

Responsibilities:

• Commercialize the intellectual property
• Perform market research to understand the competitive environment
• Evaluate potential market opportunities of each technology and their value proposition in given market
• Write non confidential technology summaries for marketing purposes
• Identify potential commercialization/licensing partners and business contacts relevant to each technology
• Contact identified partners to market technology
• Record and report market information on spreadsheet
• Assist with the evaluation of invention disclosures from chemistry faculty; working with the chemistry faculty and their research groups to track research efforts and identify patentable work
• Review and negotiating agreements relating to academic research collaborations, including collaboration agreements and inter-institutional agreements
• Assist in establishing research relationships with industry which includes negotiating and reviewing confidential license agreements, and sponsored research agreements
• Assist in the preparation of Confidentiality Agreements and other agreements relevant to the cases
• Assist in the evaluation of license terms by researching comparable transactions
• Participate in business calls and meetings resulting from marketing efforts
• Participate in the negotiation and execution of transactions resulting from marketing efforts.

Confidential

Responsibilities:

• Developed PEG-DA microwell system to enable three dimensional cultures of cancerous cell populations.
• Did Analytics on the data to identify patterns
• Extensive knowledge of OSHA and FDA guidelines
• Developed integrated protocols for experimentation
• Clinical data management for ongoing study
• Responsible for lab set-up and safety
• Responsible for clear record keeping and analysis
• Process Validation and experiment analysis. Authored IQ, OQ and PQ Protocols.

Confidential

Responsibilities:

• Performed statistical analysis of Ovarian, Lung and Breast cancer cell lines.
• Responsible for new undergraduate intern in lab techniques.
• Localizing cells with confocal microscopy.
• Used ANOVA Gage R&R to assess the effects of independent factors on variation in cancer cell growth.
• Utilized ANOVA method to measure drug sensitivity as well as their associated genomic predictors.
• Two way ANOVA was used to compare population means when the populations are classified according to 2 categorical factors. (sensitivity, reaction).
• Created comprehensive prognostic and predictive models as aids to cross cell inhibition.
• Utilized Python, Matlab and more for my data warehousing projects to analyze sample data.
• Validated lab equipment.