Md. Karim

**** * ******* ** • Catonsville • MD **228

801-***-**** • adcjv8@r.postjobfree.com

summary of qualifications

Master’s degree in Biomedical Engineering, Bachelor’s in Microbiology, minor in Chemistry, 8 years’ experience in quality assurance/ quality control, experience in several skills including Validation, Statistical Process Control (SPC), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Standard Operating Procedure (SOP), Quality System Regulation (QSR), Risk Assessment, Safety (SQF), documentation, Batch record review, Auditing, process/ method validation including clean room, injecting molds and sterilization- Gamma radiation, Ethylene Oxide (ETO) and dry heat- steam Sterilization, perform HPLC, Gas chromatography–mass spectrometry (GC-MS), Plating, Staining & Growing Bacteria, Aseptic techniques, Real Time/RT-PCR, DNA/RNA/Protein Isolation, Purification and Analysis, Monoclonal antibody, fermentation, Cell Culture, Elisa, Western Blot, SDS-PAGE, Lab Management, Project Management, Six sigma Green Belt Certification, ISO-9001, 13485, 11135, 11137, 17025 and FDA regulations. Excellent computer skills- Minitab, Agile, E1 and SAP system, Track Wise software and Microsoft Office (PowerPoint, Excel, and Word).

Work

QUALITY ENGINEER

Breethe, Baltimore, MD Nov. 2019 - Present

Managing Quality department

Managing suppliers and auditing suppliers

Submit 510K for artificial Kidney -responsible for product biocompatibility, sterilization validation and process validation

Write method validation procedure and template

Write performance qualification (PQ) procedure and template

Supporting production, working on nonconformed products, reviewing and approving DHRs

Auditing suppliers to make approve suppliers

Supporting ISO class 7 cleanroom and working with vendors to measure particles, bioburden and endotoxins.

QUALITY ENGINEER /SIDE VALIDATION LEAD

Becton Dickinson, Baltimore, MD 2015- Nov. 2019

Performed complaint investigation, monthly/quarterly trending/ CPI and CID

Lead CAPA, process improvements and supplier’s continuous improvement

Worked on Infuse project ($20 million project) to automate processes

Worked with suppliers, supplier transfer, performing validation and implementing corrective action

Supported production, review DHR, update DHF, improving assembly process

Performed IQ, OQ, PQ for process, equipment, and method validation following FDA and ISO 13485 standards

Wrote and reviewed validation protocols, deviation and final report

Wrote, reviewed and released documents

Design reviewed for new process, perform product/ design FMEA, FAT (factory acceptance test) and SAT (site acceptance test)

Designed MSA and testing methods to validate equipment and processes including bioreactor, Sluf1 &2, K line, Label and Printers, stacker, vision system, sensors, 2D barcode, label application, reject gate, in feed, auto baggers, UV treatment for sterilization.

CAPA ENGINEER

Greatbatch Medical, Fort Wayne, IN 2014-2015 (Contract job)

Supported and performed customer complaint investigations by working in collaboration with different departments.

Followed GB Core Beliefs and all safety and quality requirement.

Independently perform assignments and complete investigations on time.

Completed Medical Device Reports (MDRs) and Medical Vigilance Reports (MDVs).

QUALITY ENGINEER III

Thermo Fisher Scientific, Inc., Fredrick, MD 2013 – 2014

Implemented Quality Management System (QMS), performed Risk Assessment, Problem Recognitions (PRs) and Corrective action and Preventive action (CAPA) for the regulated and non-regulated diagnostic products related to customer complaints, process validation and process improvement using Track Wise software.

Improved document review process and work as a document control approval (DCA) for the document review and creating new documents such as Standard Operating Procedures (SOPs), WINs (Working instructions) and Forms using the agile software.

Performed batch record review for the raw materials and for the finish products and release them using EI and SAP system. Audited and validated Manufacturing and Distribution processes, procedures, documentation, batch records following company’s QSR, FDA -21 CRF 210, 211,820, 821 and ISO 13485 standards.

QUALITY ENGINEER

Baxter International Inc., Medina, NY 2013 – 2013 (Contract job)

Performed Corrective action and preventive action (CAPA), Risk Assessment, related to FDA observations, customer complaints, process validation, process improvement and product design.

Wrote and implemented Standard Operating Procedures (SOPs) related to process improvement, process validation, product quality check, environmental monitoring, FDA (21CFR-820) and ISO 13845 regulations and standards.

QUALITY ASSURANCE SUPERVISOR

Corning, Salt Lake City, UT 2010 – 2013

Supervised QA techs and provided trainings and resources to accomplish their works. Conducted testing as needed to support daily demands for production as well as new product introduction.

Lead and investigated derivative products, improved processes, auditing, product qualities, cost reductions using Lean management, 5S, kaizen, Six Sigma skills like DMAIC, FMEA, FTA, Risk management, Mini tab software and reported them to top management.

Identified and implemented process improvement initiatives that improve workflow and productivity using Six Sigma technology, Design History Files (DHF), Device Master Records (DMR), and Device History Records (DH) and so on.

RESEARCH TECHNOLOGIST (MICROBIOLOGY AND MOLECULARBIOLOGY)

Johns Hopkins University, Baltimore, MD 2009- 2010

Investigated risk factors (aflatoxin and HBV) relate to liver cancer in Shanghai, China population. Several protocols

had been followed including

Real Time PCR to investigate the mutation in codon 249 of the TP53 gene & quantify Line1 DNA in cancer patients.

Followed GLP, GOP, SOP and FDA and EPA rules and regulations.

Studied Line one DNA as a marker for cancer diagnostic.

RESEARCH ASSISTANT (MICROBIOLOGY AND MOLECULARBIOLOGY)

Brigham Young University, Provo, UT 2002- 2006

Investigated the inactivation of Prion Infectivity by Reactive Oxygen Species (ROS). Our research group was able to

eliminate Prion infectivity by a precise measured dose of Ozone. To accomplish this study, following procedures had been

performed

Cell Culture (Vero, Raji, & Jurkart, N2a).

Assayed for infectious Prion with Cell and Western Blots.

Performed PCR to amplify the rRNA gene to study the 16S-like rRNA Expression in different plants.

Education

Master of Science in Biomedical Engineering 2009

Wayne State University, Detroit, Michigan

Bachelor of Science in Microbiology – Minor, Chemistry 2006

Brigham Young University, Provo, Utah

Six Sigma Green Belt Certification 2009

Wayne State University, Detroit, Michigan

Certified Quality Engineer (CQE) (Pending) Dec 2013 - present

relevant skills

Experimental Design Software – Track Wise, Minitab, EI and SAP system

Batch record reviews Project Management

Validation Computer Programming (JAVA, Math lab)

Auditing FDA regulations and ISO standards

CAPA Six Sigma Green Belt Certification

Quantity & Quality Analysis Chemistry Microsoft Office (PowerPoint, Excel, and Word)

Contact this candidate