Resume

Resume

When you’re in pursuit of the perfect new job, a perfect resume/CV is what you need. Creative Copy Indy is here to show you how it’s done. We love highlighting the way in which your skills are a perfect match for the position you have your eye on. See below for a solid sample of Creative Copy Indy’s resume/CV writing!

Strong, Stylistic Resume Example

Client Name

Client Address and Contact Information

 

Quality Assurance Management

  • Knowledgeable professional with 8+ years of experience in the area of Quality. Achieved successful external inspections by strengthening internal audit process, demonstrating importance of Quality Management Systems, amending process improvement program and implementing standards and regulations for healthcare and manufacturer professionals.

Areas of Expertise

  • Designed Lean Process Improvement
  • Statistical Process Control
  • Root Cause Analysis/Corrective Action/Preventive Action
  • Internal Audit and Product Release
  • Federal, States and Local Regulations and Standards (Regulatory Compliances)
  • Failure Mode Effects Analysis (FMEA)
  • Quality Function Deployment (QFD)
  • Quality Trainings

Professional Experience

Quality Assurance Manager, 2015 – Present

  • Developed and implemented all Standard Operating Procedures and policies to support business and federal regulatory requirements, such NMDP, ICH Q8-Q10 Guidelines, and 21 CFR Parts 210-211, 600, 820, 1270, and 1271
  • Implemented and managed internal audit program to support federal regulatory standards and NMDP policy
  • Oversaw Deviation, CAPA, Change Control, Adverse Events, and the Non-Conformance program
  • Oversaw performance of team members, including delivery of annual performance assessments and evaluations
  • Acted as point person for all regulatory inspections
  • Created set of quality metrics to gauge all Quality related performances and identify areas for process improvements
  • Originated and implemented improvements to Quality procedures
  • Collaborated with team members to identify areas of opportunity to support the continual improvement of the Quality Management System
  • Provided HIPAA, cGMP, cGTP, regulatory standards, confidentiality and documentation training for the organization
  • Worked with other Quality Assurance members to create, improve and normalize QA and operational processes according to business goals
  • Submitted licensure applications with all applicable regulatory agencies and registries
  • Established Quality Management System and provided Quality Management reports (Quality Systems Management Reviews) to the Managerial Team

The Community Blood Services — Montvale, NJ

Quality Manager, 2011 – 2015

  • Oversaw three departments: NJ Cord Blood Bank, Immunohematology, and Technical Services
  • Facilitated and articulated (illustrated or reinforced) Quality Management Systems by addressing all non-conforming issues, incidents, and internal audit outcomes. Improved TAT of report submissions from Directors by 85%
  • Developed SOP and regulatory training program and mentored laboratory staff to decrease errors by 95%
  • Achieved zero citations or non-conformances from external agency inspections by performing periodic mock inspections and comprehensive audit.
  • Collaborated with Directors to improve internal competency assessments and external proficiency testing programs
  • Acted as point of contact for FDA, AABB, and NY State inspectors
  • Oversaw Internal Auditing System, Deviation, CAPA, and Change Controls to ensure testing and manufacturing processes met all standards and regulations
  • Oversaw quality programs for testing, incoming materials and reagents to ensure quality of the products
  • Coordinated and completed review of batch records, product test results and disposition of product.
  • Approved and implemented Standard Operation Procedures to support regulatory requirements, such as ICH Q8-Q10, ISO 13485, and 21 CFR Parts 210-211, 600, 820, 1270, and 1271
  • Spearheaded and coordinated all validations of laboratories’ test methodologies and procedures
  • Complied with multiple license and accreditation programs
  • Oversaw vendors to ensure service levels met established terms, conditions and performance as illustrated in agreements.

National Cord Blood Program at the New York Blood Center — Long Island City, NY

Assistant Lab Manager, 2001 – 2011

  • Improved quality processes in HLA laboratory according to regulatory requirements
  • Participated in ASHI and NYSDOH inspections, ensuring all standards and regulations were met
  • Participated in FDA BLA inspections
  • Worked with vendors for contract negotiations
  • Produced and achieved 0 citations or non-conformances from external agency inspections by performing periodic mock inspections.
  • Oversaw quality control programs, materials and stability of all reagent activities according to official regulations
  • Created and implemented Standard Operating Procedures for laboratory processes
  • Managed budget for operations of department. Developed and validated new laboratory methodologies
  • Identified and resolved incidents and test performance issues proactively
  • Contributed to preparation of Quarterly Quality Assurance Report accurately

License and Certifications

  • Quality Improvement Associate, ASQ
  • Certified Six Sigma Green Belt
  • New York State Licensed Clinical Laboratory Technologist

Education

Master of Business Administration, Project Management 

University of Phoenix, Expected 2016

Master of Arts in Biological Sciences

Hunter College, New York, NY, 2003

Bachelor of Science in Biochemistry

Cook College, Rutgers University, New Brunswick, NJ, 1990