Consultant Resume

Posted on: 2011-07-07

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Resume:

Summary of Qualifications

Professional with a diversified background and years experience in Compliance and Quality Assurance.

Proficient in compliance, auditing, investigations, Corrective and Preventive Action (CAPA), product complaint, adverse event evaluation, SOP development and assessment. Industry experience specialty in Quality Assurance, Quality Control, Regulatory Affairs, Utilities/Facility, FDA Regulations (CFR /, ), ISO / and ISO , CAPA, Regulatory and Quality, within the Pharmaceutical and Medical Device industries.

Professional Experience

- Client: Philips Healthcare, Cleveland

Consultant

Retrospective review of class III devices within Philips healthcare.

Retrospective review of CT (Computer Tomography ) manufacturing Defect Reports (DR) for CFR Part compliance

Retrospective review of NM (Nuclear Medicine ) manufacturing Defect Reports for CFR Part compliance

Retrospective review of PET/CT (Positron Emission Tomography ) manufacturing Defect Reports for CFR Part compliance

Retrospective review of DR’s and its subsequent disposition for compliance with elements of FDA CFR to include but not limited to design control, document control, nonconforming material, process and process control, recordkeeping, ISO , ISO Risk Management, Good Documentation Practice (GDP) and statistical techniques

Review all DR related procedures in PH, Cleveland site to ensure they are in compliance with all pertinent regulations like CFR and ISO

Audit Manufacturing process and QN inputs in Access database

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Most importantly, created a positive impact on the client\\\\\\\\\\\\\\\'s mind set to further improve their quality.

- Client: Philips Healthcare, Best, Netherlands

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Consultant

Retrospective review of class III devices within Philips healthcare.

Retrospective review of IXR (interventional X-Ray Systems) Quality Notifications for CFR Part compliance

Retrospective review of MR (Magnetic Resonance Systems) Quality Notifications for CFR Part compliance

Retrospective review of process CAPA for compliance

Audit Manufacturing process and QN inputs in SAP database

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Created protocol, provided training both in grp setting and one-on-one coaching on key CAPA elements to ensure understanding of FDA requirements.

Performed adequacy review on completed elements and proposed changes to close gaps.

Most importantly, created a positive impact on the client\\\\\\\\\\\\\\\'s mind set to further improve their quality.

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Provide training for Quality Tech and Engineers on CAPA process, GMP, CFR and ISO

- Quality Engineer II Complaints Investigation, Boston Scientific, Spencer, IN

Provided leadership role on championing complaint investigation across functional areas within the facility.

Provided project direction, coaching, and mentoring for engineering and technical team personnel.

Proactively investigated, identified, and implemented best-in-class Quality Engineering practices.

Established effective corrective action plans as they relate to complaint closures.

Lead in implementation of quality assurance plans, and CAPA systems documentation to meet or exceed internal and external requirements.

Acted as an effective leader or team member in supporting quality disciplines, decisions, and practices.

Applied sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Reviewed and approve product, process, software qualification and validation and other change control related documentation of complaints file.

Acted as an effective leader or team member in supporting product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Generated internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.

Participated in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigated and analyze customer/internal complaints.

Identified industry best practices. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Lead/actively participate in Barrier removal team activities (BRT).

Utilized standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process capabilities and assist Manufacturing Engineering and Process Development Engineering in setting drawing tolerances (i.e. perform qualitative and quantitative data analysis).

Exposed to Lean Management in and regulations pertaining to GMP/QSR, ISO/ISO/CMDR/CE and associated regulatory agencies.

- Client: Regulatory: Stryker Orthopaedics, Mahwah, NJ

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Consultant

Major Accomplishments: Compliance / Reporting Analyst

Created and initiate PER files transcribing faxed data into Complaint Database (Track Wise).

Monitored complaints for product trends and notify management of events requiring immediate action.

Followed up with, Patient’s, Sales Reps and hospitals to obtain applicable information pertaining to reported events.

Corresponded with FDA office on additional complaint data and CDRH Letters.

Obtain product function information in collaboration with engineers to determine reportability.

Reviewed PERs for AE reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations (MDD).

Ensured timely completion of MDR/MDV rationales and initial, supplemental and final incident reports to FDA and other Competent Authorities within specified time frames.

Monitored and trend MDR activity and prepare weekly status reports to management.

Participated in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiative.

Maintained knowledge of applicable related Federal and Foreign regulations pertaining to Medical Device Reporting through training, reading, etc Writes, reviews, and approves, as necessary, summaries of failure investigations and complaint investigations.

Assisted department with Recall letters and customer correspondence.

Performed training for in-house and field personnel on PER and MDR reporting.

Prepared ad-hoc reports of complaint and MDR trends.

Provided MAUDE database searches and reports as required.

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- CAPA Coordinator, Fujifilm, Stamford, CT

Responsible for FUJIFILM Medical Systems U.S.A., Inc. Complaint processing and reporting to assure the company’s compliance with FDA QSR, and global standards.

Worked with owners facilitates timely closure of Complaints, NCRs and Investigations.

Responsible for the coordination of timely QRB meetings, investigation to root cause, and resolution of all complaints and Non-conformance Reports (NCR) received.

Initiated Investigation worksheets on behalf of Ex. Committee as a deliverable from Management Review, as well QRB as needed.

Initiated CARs for all internal requirements. Evaluates CAR worksheets and reconciles with CAR owners any outstanding issues or shortcomings in the worksheet contents.

Regular communications with CAR, NCR, and Investigation database administrator for FMEA updates, closures, authorizations etc.

Coordinated all necessary ancillary documentation for Contact person to forward to OSD.

Participated in Monthly CAPA meetings, and Bi-weekly QRB.

Assisted Corrective Action Report (CAR) owners in the development of the corrective and/or preventive action plan to assure it adequately addresses and resolves the complaint and/or complaint trend observed.

Provided periodic trend analysis reports.

Wrote, reviewed, and approved, as necessary, summaries of failure investigations and complaint investigations.

Assisted in the investigative process by coordinating tasks across department lines.

Reviewed complaint, investigation and NCR documentation for completeness of content prior to its submission to the Quality Review Board.

Monitor and trend complaint activity and prepare weekly status reports to management.

Exposure to Lean Management in and regulations pertaining to GMP/QSR, ISO/ISO/CMDR/CE and associated regulatory agencies.

- Client: Wyeth Pharmaceutical, Pearl River, NY

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Consultant

Major Accomplishments: QA Specialist

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Responsible for providing Quality Assurance support to Manufacturing, Validation, Engineering and Testing Operations relative to the production of commercial and clinical products.

Reviewed batch records and gives disposition (approval, rejection, etc.) to the material produced.

Reviewed SOPs, protocols, analytical results and investigations associated with manufacturing operations in Database (Track Wise).

Responsible for a diverse and challenging activities, all of which are related to setting and maintaining quality standards aligned with US FDA, cGMP and other applicable international GMP regulations and guidance.

Have working knowledge of fundamental technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant Wyeth SOPs, and receives minimal supervision on routine assignments.

Worked with project teams providing services to the manufacturing operations for Drug substance and Drug Product to assure appropriate consistency in GMP systems applied across both clinical and licensed products.

Inspected Raw materials for approval/rejection based on Acceptance Criteria.

- Laboratory Manager, Barnard College, Manhattan NY

Provided analysis for a web-based financial supply chain software solution.

Ordered laboratory equipments and supplies for dept.

Opened and closed accounts with different vendors.

Inspected and fix many laboratory equipments.

Maintained and disposed hazardous materials.

Handled the proper disposals of lab wastes (both chemical and animal corpses).

Over saw the cares of over lab rats and mice.

Worked directly with department chair and all professors to assure a well run dept.

Support Battalion - Recruit Administration Center, Parris Island, SC

Gave recruit-training classes.

Record keeping, prepared graduation and promotion warrants.

LAN accounts-Coordinated all messages and personnel accountabilities.

Secretarial work including record keeping, labeling and filing.

Receptionist at on-base receiving center.

Clients

Philips Healthcare

Fujifilm

Stryker Orthopaedics

Barnard College

Wyeth Pharmaceutical

United State Marine Corp

DATABASE:

Trackwise

Agile

Access

Clarity

Lotus Notes

Clearquest

Education

Bachelors of Science, Biological Sciences, , Rutgers University.

Masters, Regulatory Affairs, , Northeastern University.

ISO / certified Lead Auditor

Consultant Resume

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