999 Any Street • New York • NY 99999 • Phone: 999-999-9999 • Email: firstname.lastname@example.org
Erick H. Rune
SUMMARY OF QUALIFICATIONS
- Quality Assurance Professional with extensive experience in the pharmaceutical and biotechnology industries
- Significant knowledge Mistake #1 click here of current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Food and Drug Administration (FDA), Health Canada’s Therapeutic Products Directorate (TPD), College of American Pathologist guidelines (CAP), Clinical Laboratory Improvement Amendments (CLIA), ISO Standards, New York State and New Jersey State regulations
- Certified Quality Auditor (CQA) with proven ability to manage internal, vendor, client and regulatory audits
- Experience auditing suppliers and service providers such as Contract Research Organizations (CRO), clinical and diagnostic laboratories, irradiation and packaging companies
- Known for successful implementation of corrective and preventive action program (CAPA) in dealing with deviations and complaints
- Advance working experience in Laboratory Information Management System (LIMS)
- Extensive knowledge and experience with computer validation and 21 CFR Part 11 regulations
- Excellent communication, organization and coaching skills
RELATED WORK EXPERIENCE
Quality Assurance Manager, AAA Corporation, New York, NY Jan 2008 – Present
- Facilitated post-merger consolidation move of engineering test team from New York to Bellevue.
- Created new companywide quality assurance strategies and processes.
- Mentor, lead task planning, case creation, coverage analysis, automation strategy, and execution during sprint release cycles for newly hired local team & offshore in the Ukraine and India.
- Conduct daily stand up meetings, burn down analysis, and report daily sprint status and performance metrics to executive team for multiple products.
- Synchronize project resource management between corporate offices in Austin, TX. and Bellevue, WA.
- Created and maintained bug reporting and test case management system using TFS 2008 and HP Quality Center 10.
- Worked directly with IT hosting team to facilitate enhanced quality release processes for our SaaS based customers.
- Design and configure general lab and load testing environments utilizing VMware ESX server technologies for shared QA and development use.
- Performed hands on testing of multi-tier web based enterprise products founded on W2K3, W3K8, .NET, SQL, IIS, Oracle, and Autonomy. Technologies authored in java, C++, and C#.
Quality Assurance Manager, BBB Services, New York, NY 2006 – 2007
- Facilitate& Lead Computers Systems Chapter Core Requirement Global team on review & assessment of Core Requirements for the R&D GMP Continuum Space. Lead sites to perform gap analysis and action plans against Core Requirements with SOP Mapping against the approved Core Requirements. This involves 7 Global sites.
- Lead & Manage Integration Harmonization teams which include Harmonization of Clinical Stock Recovery and Inventory Control. Facilitated Kaizen Event for the Clinical Stock Recovery Process. To date, Future State has been designed and completed for both teams. Team is working towards Transition Strategy & Implementation Plan.
- Developed and Mistake #2 click here implemented a process to address QMS Integration and harmonization of multiple sites in completing Mutual Acceptance Protocol Activities. Developed Key Points of Compliance from Global Policies for legacy BBB on sites to perform compliance assessments for integration and harmonization.
- Authored summary reports for the release of Oss (Sterile and Non Sterile Manufacturing and Packaging) & Allentown (Packaging) facilities for Clinical Supply use. Facilitate meetings during integration and harmonization activities. Approved document released Facilities for Clinical Manufacturing.
- Quality Systems team member for Contractors & Suppliers, API, Computers and Manufacturing & Packaging QMS teams. Lead and support Global Metrics Harmonization and Quality Strategy of Global Policy Implementation at the Legacy BBB on Sites.
- Implemented Global Compliance Council Metrics Dashboard for 4 Global Sites for Sr. Management and Site Heads which provides high level performance view of the sites. Co-Lead Sigma Project on new Metrics Dashboard which involves 7 Global sites with the new company. IT solution to be created and implemented versus a manual process. Target Date for Implementation is October 2010.
- Co-Lead Global Compliance Council meetings that involve 7 Global sites. Discussion includes Strategy, Metrics & Compliance. Compile GCC Metrics Dashboard, presentation materials and follow up on actions identified.
Quality Assurance Manager, CCC Inc., New York, NY 2005 – 2006
- Initiating action to prevent the occurrence of any nonconformaties.
- Identify and record any deficiencies.
- Initiate solutions to any problems.
- Enforce all Quality Assurance procedures. (Company, Customer, State, and Federal)
- Perform in process inspections
- Perform outbound and final inspections.
- Investigate quality assurance issues.
- Initiate corrective action.
- Evaluate the effectiveness of those actions.
- Maintain the quality assurance program in accordance with AAR MSRP, Section J.
- Report to senior Management with the progress of the QA system.
- Assist with the creation and evaluation of procedures and processes.
- Distribute, train, and document training of employees.
- Ensure that all policies, procedures, forms, documents, records, etc. remain controlled.
- Ensure that all test, hold, and inspection points are utilized.
- Identify, document, and notify personnel of nonconformances.
- Maintain records of qualifications, certifications, training for employees.
- Ensure required vendor forms are in order.
- Close car files including billing, Maintenance closures, and AAR required closures
- Maintain calibration records on gauges and required equipment.
- Handle the Mistake #3 click here audits including in-house, customers, and government agencies.
- Handle customer complaints.
- Assist the safety manager with policies and procedures to improve our company’s safety program.
- Computer Programming Diploma, 1999.
- M.Sc. in Food Science and Technology, 1994.
- B.Sc. in Food Science and Technology, 1990.
Certified Quality Auditor (CQA), 2008.