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.

 

 

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

 

 

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