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Yyyyyy x. yyyyyy
0000 xxxxxx xxxx , xxxx , xxxxx 00000
Phone: (xxx-xxx-xxxx
abc@xyz.com
Objective
Dedicated and intelligent Quality Engineer & Validation Specialist eager to contribute extensive technical expertise as well as significant project management talents toward supporting the employer in optimizing bottom-line performance.
Qualifications Profile
Ø Advanced knowledge in IQ, OQ, PQ, FAT and SAT protocols, superior strengths in resource allocation, and substantial talents in driving compliance with GMP, GDP, and FDA requirements.
Ø Solid experience with CIP (cleaning in place) and SIP (sterilization in place) processes, GAMP (Good Automated Manufacturing Practices), PLC and SCADA systems, and operating GE Kaye Validator 2000 system.
Ø Adept in quality engineering and management, staff/team leadership, strategic planning, and skillfully communicating with personnel across all levels of an organization.
Ø Exemplary prioritization, troubleshooting, decision-making, team-building, and communication skills.
Ø Exercise strong business savvy to define goals, uncover challenges, propose modifications, and drive solution implementation to achieve measurable process improvements.
Ø Proven ability to set up, implement, and manage quality systems, interpret complex electrical/mechanical blueprints and specifications, formulate flow diagrams, create control plans, and devise quality manuals, procedures and work instructions.
Ø Excellent talents in supplier and customer relationship management.
Professional Experience
Invitrogen, Rockville, Maryland, 2006 to Present
Quality Engineer III
Ø Spearhead Compliance Department operations by diligently steering adherence to client requirements and government regulations.
Ø Apply dynamic interpersonal skills toward facilitating cohesive and cooperative efforts among operations and quality/compliance personnel.
Ø Exhibit proficiency in Failure Mode Effects Analysis (FMEA) and capability studies.
Ø Utilize Trackwise software and spreadsheets to identify, initiatiate and implement measurable process improvements.
Ø Contribute to supplier and internal quality audits, exercising sharp attention to detail and accuracy.
Ø Analyze and resolve problems of moderate scope by investigating situation or data for identifiable factors.
Ø Prepare and deliver technical presentations and serve as subject matter expert and advisor to successfully meet tight schedules or resolve challenging problems.
Ø Employ well-honed management acumen to supervise and direct groups of 10+ in various development projects; accountable for hiring, training, evaluations, mentoring and management.
Continued
Jermaine Sorrel ~ Page 2 of 2
Professional Experience (Invitrogen) continued
Senior Validation Engineer
Ø Led technical validation support through comprehensive assessments, expertly leveraging standard validation engineering techniques and procedures.
Ø Exercised strong critical thinking abilities to define, implement, administer and approve IQ, OQ, and PQ protocols, and enforce existing policies and procedures.
Ø Resourcefully established and evaluated milestones for validation department in cooperation with Quality Assurance staff and Program Lead.
Ø Relied upon to monitor and expedite efforts of contractors, subordinate engineers and project managers.
Stelex/TVG (Alpharma, BMS, Pfizer), Bensalem, Pennsylvania, 2004 to 2006
Validation Engineer Consultant
Ø Planned, executed, and finalize IQ, OQ and PQ protocols to precisely validate new and improved pharmaceutical equipment.
Ø Demonstrated exceptional organizational abilities in performing statistical analysis, scrutinizing deviations, and managing corrective action.
Ø Conducted final review of test data and reports to ensure compliance with SAT, FAT and related protocols.
Ø Innovatively created and implemented systems and tools to considerably enhance and accelerate product testing procedures.
Ø Participated in commissioning, implementation and validation of new equipment.
Ø Complied with specific criteria in preparing Master Validation Plans and ESD (Equipment Specification Documents), and supporting CCR (Change Control Requests) and CAPA (Corrective and Preventative Action Plans).
Prior Experience:
Surgical Technologist II, Medstar Health and Sinai Hospital, Baltimore, Maryland, 2000 to 2004
Administrative Assistant to Vice-President, Yahweh, Inc., Baltimore, Maryland, 1995 to 2000
Armed Security Officer, U.S. Government Facility, 1997 to 1999
Education
University of Maryland, University College, Baltimore, Maryland, to be completed May 2009
MS/MBA Degree, Management (in progress)
University of Maryland, Baltimore County, Baltimore, Maryland, 2003
BS Degree, Biology and Psychology National Dean s List
Frederick Community College, Frederick, Maryland
Certification in Surgical Technology
Professional Development & Affiliations
Ø Completed training in CGMP, GDP, and FDA rules/regulations; CSV, GAMP & SDLC; and CGLP
Ø Trained in pharmaceutical validation in manufacturing & packaging departments
Ø ASQ Training
Ø Member of ASQ
Ø Member of PMI
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