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YYYYYY X. YYYYYY Telephone: (410) 0000 xxxxxx xxxx , xxxx , xxxxx 00000 abc@xyz.com
OBJECTIVE
Quality Engineer with dynamic planning, analytical, troubleshooting, and technical skills eager to contribute talents toward actively supporting an organization in optimizing performance and productivity.
TECHNICAL & QUALITY CONTROL EXPERTISE
PLC and SCADA Systems CSV and SDLC GE Kaye Validator 2000 SIP and CIP GMP, GDP, and FDA Compliance GAMP (Good Automated Manufacturing Practices) IQ, OQ, PQ, FAT & SAT Protocols
PROFESSIONAL EXPERIENCE
Invitrogen, Rockville, Maryland, 2006 to Present
Quality Engineer III
Manage Compliance Department by consistently ensuring adherence to client requirements as well as government and regulatory agency criteria.
Liaise between operations and quality (compliance) personnel and participate in supplier and internal quality audits.
Initiate and support process improvements via Trackwise software and spreadsheets.
Exhibit proficiency in Failure Mode Effects Analysis (FMEA) and capability studies to continually and measurably fortify quality performance and results.
Senior Validation Engineer
Independently provided technical validation support through assessments, approving protocols and completing reports, demonstrating proficiency in applying standard validation engineering techniques and procedures.
Formulated, implemented and maintained IQ, OQ, and PQ protocols, interpreted and enforced existing policies and procedures, and oversaw validation equipment inventory.
Navigated and tracked efforts of contractors, subordinate engineers and project managers.
Teamed with QA and Program Lead to establish and accurately evaluate milestones for validation department.
Stelex/TVG (Alpharma, BMS, Pfizer), Bensalem, PA, 2004 to 2006
Validation Engineer Consultant
Leveraged well-honed troubleshooting expertise to plan, execute, and finalize IQ, OQ and PQ protocols in validating new and improved pharmaceutical equipment.
Performed statistical analysis, investigated deviations, and determined corrective action.
Conducted final review of test data and reports to ensure compliance with SAT, FAT and related test protocol standards.
Safely and accurately operated manufacturing equipment and sterile and aseptic processing areas and interpreted electrical and mechanical blueprints and specifications.
Provided technical input into validation plans and protocols on a project-specific basis and devised innovative systems and tools to enhance product testing procedures.
Contributed to the commissioning, implementation, and validation of new equipment.
Continued
Yyyyyy x. yyyyyy ~ Page 2 of 2
Professional Experience continued
Supported QA/QC by providing solutions to minimize risk of violating FDA rules and regulations.
Prepared Master Validation Plans and ESD (Equipment Specification Documents).
Supported CCR (Change Control Requests) and CAPA (Corrective and Preventative Action Plans).
Earlier Experience:
Surgical Technologist II, Medstar Health and Sinai Hospital, Baltimore, MD, 2000 to 2004
Administrative Assistant to Vice President, Yahweh, Inc., Baltimore, MD, 1995 to 2000
Armed Security Officer, U.S. Government Facility, 1997 to 1999
Loss Prevention Detective, JC Penney and Home Depot, ____ to ____
EDUCATION & TRAINING
MS/MBA in Management, University of Maryland University College, Baltimore, MD, 2006
Bachelor s Degree in Biology/Psychology, University of Maryland Baltimore County, Baltimore, MD, graduated 2003; GPA 3.0, National Dean s List
Certification in Surgical Technology, Frederick Community College, Frederick, MD
Additional Training:
CGMP, GDP, and FDA rules and regulations
CSV, GAMP, and SDLC
Pharmaceutical Validation in manufacturing and packaging departments
Security Clearance
Maryland State Handgun permit
CPR certified
YYYYYY X. YYYYYY Telephone: (410) 0000 xxxxxx xxxx , xxxx , xxxxx 00000 abc@xyz.com
Date
Hiring Agent Name
Title
Company Name
Address
City/State/Zip Code
Dear__________________:
I am currently seeking a challenging career opportunity as a validation specialist and am submitting my resume for your review. In advance, thank you for your time and consideration.
As indicated in the accompanying resume, I bring to you exceptional abilities in ensuring compliance with GMP, GDP and FDA regulations, an outstanding background in the medical industry, and a strong ability to develop, test and implement methods which enhance testing and quality control processes. To complement these qualifications, I will be obtaining an MBA degree this year, and offer solid organizational and planning skills which are essential as a validation engineer.
As a proactive contributor to your organization, you will find me to be a self-motivated professional committed to supporting you in achieving your objectives through resourcefulness, integrity, and exemplary communication skills. I am confident that I could be a valuable asset to your company, and look forward to interviewing with you in the near future.
Sincerely,
Yyyyyy x. yyyyyy
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