Customer Quality Specialist
Resume:
THOMAS PAIS
Spotswood, NJ *****
Home: 732-***-**** *********@***.*** Cell: 732-***-****
http://www.linkedin.com/pub/thomas-pais/9/277/555
SUMMARY
Experienced Customer Service/Product Quality Representative with extensive background in the pharmaceutical and manufacturing industries. Strengths include analyzing customer quality issues, providing relevant product information, properly resolving and triaging problems and mentoring new staff members. Strong communication skills in a regulated, cross-functional environment where acting as liaison with colleagues from other departments is needed to complete tasks.
PROFESSIONAL EXPERIENCE
MERCK & CO., INC. (Legacy Schering-Plough), Springfield, NJ 12/2000 – 02/2011
Customer Quality Specialist
Managed the intake, assessment and resolution of U.S. prescription product quality complaints and Adverse Events with a product quality component, for Schering-Plough pharmaceutical products. Determined action steps during live call that were necessary to resolve issues to a mutual and acceptable outcome using technical skills, while adhering to FDA, GXP and corporate regulations. Complaint sources were incoming phone calls via department 800-number and written correspondence received from consumers, healthcare professionals and the FDA.
• Documented and triaged all inquiries, and facilitated responses with accurate attention to detail working effectively with Quality Services, along with Drug Safety for complaints medical in nature.
• Responded to complainants regarding PQC/ADEs received through FDA MedWatch Reports while conforming to Corporate and Departmental Policies. Forwarded our case number and documentation to Global Regulatory for their database.
• Performed follow-up, as necessary, for urgent/serious complaints at threshold triggers and at the request of complaint handling partners.
• Educated the consumer/health care professional on product handling, storage and functionality. Contacted appropriate sources, internal and external, for information or literature necessary to answer a medical inquiry, while abiding by HIPAA regulations.
• Determined when Quality Investigation reports were essential and triaged these requests. Evaluated the Quality Investigation reports and communicated the written responses to the complainants. Triaged the consumer response letter generated from MedWatch inquiries to Global Regulatory for response directly to the FDA.
• Participated in validation of the departmental computer system.
• Assisted in training new staff members in proper complaint handling and adherence to SOPs.
• Awarded a long-term incentive grant (LTI) in 2010 for exceptional service over several consecutive years’ evaluations.
COMPAC INDUSTRIES, Edison, NJ 02/1992 – 12/2000
Customer Service Supervisor
Processed orders, technical information requests, credits and quotes for the Industrial Tape Division received from customers and a team of manufacturers’ representatives.
• Handled the processing and sending of samples requested.
• Assisted in production planning, scheduling and follow-up of orders.
• Assisted in procuring of raw materials.
THOMAS PAIS
Page Two
Home: 732-***-**** *********@***.*** Cell: 732-***-****
EDUCATION
BA, Business Administration, Rutgers University, New Brunswick, NJ
PROFESSIONAL DEVELOPMENT AND TRAINING
(partial listing)
Unwritten Laws of Business, Turning Conflict Into Collaborative Solutions, Telephone Technique, Adverse Event Reporting, Management of Product Complaints and Medical Inquiries, Privacy Awareness.
TECHNICAL SKILLS
Word, Outlook, Excel.
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