Customer Service Medical Device

DAVE TAYLOR

** ***** ****, **** *********, NJ ***16

732-***-**** Cell xaezv7@r.postjobfree.com

Summary

Dynamic, versatile Compliance Professional with an exceptional background in ensuring compliance within biopharmaceutical and medical device environments. Outstanding track record of increased responsibility. Superior leadership, communication, and interpersonal skills within culturally diverse settings. Excellent analytical, critical thinking, problem solving, and organizational abilities. Highly motivated self-starter, easily work independently, on a team, or as a leader. Current on regulations effecting the Biopharmaceutical/Medical Device industry including thorough knowledge of 21 CFR 820, ISO 9001, cGMP, OSHA and FDA Regulations. Served in the United States Navy (Honorable Discharged).

KEY COMPETENCIES

• LiveLink

• Pilgrim Smartsolve 7.04

• Oracle E Business Suite

• Documentation Accuracy

• Batch Record Review

• Complaint Management System (Infomed/ CATSWeb)

• Intellivenge

• Microsoft Word, Excel, Access, PowerPoint, & Outlook

• Adobe Acrobat Standard

• Buffer Preparation

• Team Member Training

• Product Sampling

• Steam Sterilization

• Aseptic Technique

• Environmental Monitoring

• Volumetric Filling

• Time Management

PROFESSIONAL EXPERIENCE

DENDREON, Morris Plains, NJ 2010- 2011

Cell Processing Technician II

Aseptically manufacture commercial human blood therapeutics in a clean - room environment.

• Accurately weigh, measure, and check raw materials to ensure batches manufactured contain proper ingredients and quantities.

• Meticulously monitor, coordinate, and execute timely completion of process documentation.

• Reviewed batch records to ensure batch production record were free from non conformances and errors.

• Maintain standard operating procedures (SOPs), batch records, and other applicable documentation to comply with regulatory requirements and good manufacturing practices (GMP’s).

GENZYME, Ridgefield, New Jersey 1998 – 2010

Compliance Specialist (2007-2010)

Accurately logged initial data into global complaints system (CATSWeb).

Investigated and evaluated assigned complaints for root cause by utilizing due diligence and best practices when conducting and completing an investigation; achieved timely closure on complaints by analyzing NCR, CAPA, analytical, batch record review, and biological data associated with the product.

• Communicate all complaint trends with manufacturing personnel.

• Performed an inspection non-complaint product returned to Genzyme.

DAVE TAYLOR

Phone 732-***-**** xaezv7@r.postjobfree.com

• Played a key role in implementing CATSWeb database.

• Significantly increased productivity and accuracy by conceptualizing, communicating to systems administrators, and implementing ways in which data entry into the database could be established as default verbiage in certain fields that contain consistent information.

Aseptic Technician & Group Leader, Aseptic Production (1998-2007)

Responsible for overseeing 8 team members while they performed such activities as compounding, filtration, environmental monitoring, and volumetric filling in a class 100 sterile environment; set up, operated, and troubleshot automated filling equipment in a sterile environment.

• Ensured processes were executed meeting specifications according to batch production records by monitoring, verifying, and accurately documenting manufacturing processes.

• Facilitated the highest level of proficiency by continuously training and retraining employees as needed; provided advice to the production manager on annual performance appraisals and disciplinary action as required.

• Assisted the validations department on validating and revalidating of all sterile manufacturing production equipment.

• Achieved microbiology's annual aseptic gowning qualification.

Clean Tech Carpet Cleaning, Sayreville, New Jersey 1996 – 1998

Owner & Operator

Provided outstanding customer service to commercial and residential clients by utilizing the highest quality product in the industry and carefully scheduling service calls in order to meet all requests on a timely basis.

• Generated increase revenue by cultivating subcontracting relationships with several major carpet cleaning companies in New Jersey.

• Additional responsibilities included hiring, training, and managing 6 employees, ordering supplies as needed, repairing all equipment, and overseeing all administrative functions of the business.

EDUCATION

BS, Business Management, Project Management Concentration, (In Progress)

COLUMBIA SOUTHERN UNIVERSITY, Orange Beach, Al.

AS, Network and Communication Management

DEVRY UNIVERSITY, North Brunswick, New Jersey

TRAINING

University of Tennessee College of Pharmacy Memphis, Tenn.

Preparation of Parenteral Products (Training Course)

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