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.
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.
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.
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).
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
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
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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