Medical Billing Quality
Resume:
SUMMARY
Detail-oriented Quality Assurance Specialist, with 20 years experience in the biotechnology/pharmaceutical industry. Advanced knowledge and experience with cGMP manufacturing, quality and compliance. Reviews and interprets batch record documentation and related materials in accordance with SOPs. Initiates correction of error and omission. Proficient in Microsoft Office Suite: Word, PowerPoint, Excel, and Access.
PROFESSIONAL EXPERIENCE
Legend Biotech, Raritan, NJ 9/2020 – Present
Quality Assurance Person In Plant (CAR-T)
Serves as a Quality person in plant in support of cell therapy manufacturing.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Review and approve manufacturing procedures and batch records.
Real time review of all documentation and reporting in support of process unit operations and release activities.
Strive to reduce non-conformances in supported areas by proactively driving compliance.
Perform tasks in a manner consistent with the safety polices, quality systems, and cGMP requirements.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Celgene/Bristol-Myers Squibb, Summit, NJ 3/2019 – 8/2020
Quality Assurance Specialist, Shop Floor (CAR-T)
Ensured manufacturing compliance with procedures and batch records.
Real time review of batch records and shop floor documentation.
Issued production batch records and product labels to operations.
Strong investigation experience.
Knowledge of quality processes including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Raw material receipt and pack out for drug product release.
Writing and initiating deviations.
Served as a member of decision making triage team for events occurring during processing.
Writing and updating SOPs.
Provided oversight to operations on the shop floor supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
Performed line clearance each day before the start of production activities.
Implemented and ensured adherence of appropriate regulations and Celgene quality standards.
Roche Molecular Systems, Branchburg, NJ 7/2018 – 3/2019
Diagnostic Technician
Performed tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards.
Followed all department work instructions, SOPs, OSHA safety regulations.
Executed all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines.
As part of the production team, performed in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects.
Used basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc.
Executed SAP and electronic batch record transactions to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliations, etc.
LifeCell Corporation/Allergan, Branchburg, NJ 6/2000 – 10/2017
R&D Process Development Technician II
Performed laboratory tests that ensured the product/device to function as intended, i.e., verification and validation of the process.
Monitored the performance of equipment and recommended solutions for continuous improvement which streamlined the process.
Worked with manufacturing/engineering group to scale up, validate and transfer processes and products from the development stage to the commercial manufacturing stage.
Provided feedback to technicians to improve new developmental tissue processes.
Performed final verification and inspection of product and batch record.
Created and submitted project expense reports to management on a monthly basis.
Ensured optimal laboratory practices by utilizing experience in clean room environment and aseptic processes.
Production/Manufacturing
EDUCATION AND TRAINING
Associate in Applied Science, in Business Marketing and Management, Berkeley College, Woodbridge, NJ
LICENSES/CERTIFICATES
Certificate in Medical Billing/ Coding, Montclair State University, Upper Montclair, NJ
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