Quality Auditor, Quality Engineer, Quality Assurance Specialist, Regulatory affairs Specialist with 5 years experience looking for a Direct Contributor position.
Quality Auditor, Quality Engineer, Quality Assurance Specialist, Regulatory affairs Specialist with 5 years experience looking for a Direct Contributor position.
Direitos autorais:
Attribution Non-Commercial (BY-NC)
Formatos disponíveis
Baixe no formato TXT, PDF, TXT ou leia online no Scribd
Quality Auditor, Quality Engineer, Quality Assurance Specialist, Regulatory affairs Specialist with 5 years experience looking for a Direct Contributor position.
Direitos autorais:
Attribution Non-Commercial (BY-NC)
Formatos disponíveis
Baixe no formato TXT, PDF, TXT ou leia online no Scribd
3207 Acklen Dr SW coc924d2@westpost.net Apt # D28 Huntsville AL 35805 (256)4795636
Objective: Quality Assurance and Regulatory Affairs position in a biotechnology,
Pharmaceutical or medical device company focusing on quality control and regula tory affairs. Highlight of Qualifications Extensive knowledge of quality assurance, In-depth knowledge of ICH GCP guidelines, GMP, GCP, GLP Extensive ICH GCP training, Control of Pharmaceutical Products including Product Testing, A self-motivated, resourceful and diligent individual with strong analytical, in vestigative, problem solving, decision making, organizational, communication and interpersonal skills. Experience: Kriger Research Center Inc. Canada Quality Assurance Officer Experience in application of GMP, ICH, FDA and TPD guidelines in relation to qua lity issues. Generated audit and non-conformance reports for in-line and in-process tests in both manufacturing and laboratory settings. Method Development and Validation Developed and validated analytical methods Performed process optimization and validation Performed cleaning validation on manufacturing equipment Documentation Prepared protocols, SOP's and other technical documents in accordance to in-hou se, compendial and regulatory requirements. Compliance Auditor Prepared the audits of the QC lab with a primary focus on reviewing laboratory r ecords. Generated laboratory report patterns outlining observations and suggesti ons for corrective actions. QA Documentation Associate Generated a raw material specification and a f inished product specification for Product rhEGF which will be supplied to the US A, Formulary Consultant and Technical Writer Compiled concise report outlining the drug submission req uirements of all Canadian provinces Compose d a detailed SOP detailing the use an Analytical balance. QA Trainer Provided an orientation session for n ew employees describing the pharmaceutical manufacturing environment. Created a flow chart outlining the processes and cri tical controls involved in a pharmaceutical environment, from the time raw mater ials are received, to the manufacture of the product, and the shipping of the fi nished packaged product to consumers for use applying the knowledge of GMP, GLP and GCP Matsu Alabama Inc., Huntsville AL 2006 - 2010 Quality Auditor * Ensure that all Quality engineering processes for new product planning report (NPPR) milestones are met * Maintaining product integrity by ensuring parts provided to manufacturing met quality standard for engineering specifications, ISO 9001/2000, TS16949 and Six Sigma standards * Create advanced product quality planning (APQP) requirements, including but no t limited to, process failure mode cause and effect analysis (PFMEA), Process Fl ow Charts, and Process Design Sheets * Working experience of SPC, JIT and lean manufacturing * Applying DMAIC methodology in solving quality related issues * Direct interface with customers and suppliers in resolving quality issues * Ensure that process engineering is aware of any new processes needed to suppor t new product launch requirements * Using 8D and 5WHY quality technique in resolving customer quality issues * Performing internal and external audit * Supervising teams of quality inspectors and evaluating their daily performance * Provide process data to verify capability of critical characteristics prior to high volume trials * Communicate within manufacturing engineer, any technical developments that may aid in increasing productivity, reducing scrap, or providing ergonomic improvem ent to any existing process * Lead continuous improvement activities necessary to reduce machine downtime, r educe scrap, and increase productivity
West Wind Technologies, Huntsville, AL
2005-2006 Quality Control Technician. * Created and reviewed process, installation and instructions for accuracy * Use engineering drawings and blue prints to perform inspections * Ensured information placed on drawing was accurate and functional in accordanc e with system requirement * Interpreted customer specifications * Performed receiving, in process and final inspections on electronic circuit bo ards * Maintained and calibrated hand inspection tools and fixtures * Performed continuity test, bonding test and checked torque on complex mechanic al and electrical assemblies * Knowledge of AS9100 Quality Management System Requirements * Deep knowledge of quality procedures and First Article inspections * Working knowledge of ISO 9001-2000 and JIT * Use of different measuring devices, e.g. (calipers, micrometers, protractors, height gauge, dept gauge, pin gauge, multi-meter etc.) * Use of government requirement standard e.g. (IPC-A-610B, IPC/EIA-J-STD 001, IS O 90001: 2000 etc) EDUCATION Kriger Research Center Inc. Canada QUALITY ASSURANCE & REGULATORY AFFAIRS May 2010 ICH, GLP, GCP, GMP GUIDELINES PROGRAM Alabama A&M University, Normal, AL M.S Industrial Technology May 2008 GPA: 3.41/4.0 Federal University of Technology Akure. Nigeria B.S, Electrical and Electronics Engineering May 2003 3.47/4.0 HONORS / ACTIVITIES Technology Department Financial Secretary, 2001-2003. Deans list, 1998-2002