Joseph A. Fiore

**** ****** **** *****

Durham NC 27704

919-***-****

acrp4p@r.postjobfree.com linkedin.com/pub/joseph-fiore/13/26/846/

Summary of Skills and Qualifications

■ Proficient in MS Office, Word, Excel, Outlook ■ Detail oriented

■ Task prioritization planning ■ Supervise/Train coworkers

■ Prepare correspondence documents ■ Interpersonal and team work

■ Schedule and coordinate seminars ■ Data entry experience

■ Project management coordination ■ Strong customer service skills

■ Schedule and maintain calendar ■ Filing and record keeping

■ Excellent writing, editing/proofing skills ■ Community outreach liaison

■ Reconcile/ Review Master Batch Records

Professional Experience:

Pharmaceutical manufacturing training specialist for Eisai Inc supporting oral solid dose, packaging, warehouse, and parenteral operations. Responsible for developing, conducting, and monitoring training programs for employees utilizing blended learning concepts including one-on-one, instructor lead, and electronic document/ virtual training.

Manufacturing Technician, Team Leader and Supervision of oral solid dose, liquid, and suppository manufacturing operations. Two year Technician, Two year Team Leader, and Four year Manufacturing Supervisor role in Eisai Inc oral solid dose manufacturing department.

Eisai Inc. RTP (Research Triangle Park) North Carolina (May 2013 – December 2014)

Production Support Specialist / Controlled Document Routing (Parenteral Operations)

Managed the Eisai Inc. Parenteral Operations employee orientation, training and development program.

Maintained training records and performed annual training curriculum reviews. Supported employee development and continuing education opportunities for employees. Supported management in the creation of job task goal oriented employee development plans and OJT (on the job) skill assessments.

Assisted with creation of SOP's to support introduction of new equipment and revision of SOP’s to ensure documents CGXP compliant.

Routed electronic GMP related red-lined draft copies of controlled documents received from parenteral operations employees to assigned SME (Subject Matter Experts) management, and QA for approval of proposed revisions.

Submitted hard-copy training records for controlled document related training of personnel to QA as required. Maintained department reference copy files in employee training binders.

Conducted tours of Eisai Parenteral manufacturing facility for new hires and site visitors as requested.

Eisai Inc. RTP North Carolina (June 2006 – May 2013)

Employee Training Specialist (Oral Solid Dose manufacturing, packaging, warehouse)

Managed the Eisai Inc. oral solid dose operations employee orientation and training program. Coordinated manufacturing orientation training for new manufacturing hires and ex-patriot employees/ visitors

Supported employee development resources and continuing education opportunities for manufacturing, packaging, and warehouse employees. Fulfilled role by working with vendors, department management and team members in the creation of job task, goal oriented employee development plans, OJT (on the job) skill assessments, and LMS (learning management system) based knowledge retention quizzes.

Team member of an on-site Eisai Inc SAP implementation team. Delivered initial internally/ customized SAP software training to incumbent manufacturing employees. As necessary delivered SAP training to new hires.

Knowledgeable in LMS Plateau based Electronic Document Management EDNA (Every Document Now Available), Articulate, SAP tutorial simulation, Info-Pak, and MS office.

Conducted on-site tours of the manufacturing, packaging, and warehouse operational areas for academic groups (Biowork students)/ professional organizations and Eisai Inc ex pat and USA employees visiting from other corporate locations.

Collaborated with QA (quality assurance) department to enhance LMS computer based training and controlled document review training needs. Identified opportunities proactively to improve end user customer experience.

Developed and evaluated course and training materials for off -site training sessions, Identified activities and resources and developed training objectives. Coordinated training session logistics with outside consultants / vendors and local community colleges.

Compiled maintained and submitted to QA, hard-copy training records for controlled document related training of personnel as required.

Eisai Inc. RTP North Carolina (December 1998 – June 2006)

Manufacturing technician member of oral solid dose manufacturing team. Responsible for set-up, operation and cleaning of (dispensing, granulation, compression, tablet coating and printing) process areas and related equipment.

Manufacturing team leader of oral solid dose manufacturing team. Responsible for GMP compliant oversight of process area activities and effective training of team members and utilization of available resources. Coordinated scheduled and unscheduled maintenance activities with engineering department to ensure minimal disruptions to planned production schedule.

Manufacturing team Supervisor of oral solid dose manufacturing team. Responsibility for all aforementioned process area activities as well as the development and performance evaluation of direct report team members.

Additional Employment Information:

New Hanover Regional Medical Center, Wilmington North Carolina (1996 – 1998)

Respiratory care therapy assistant

AAI Wilmington North Carolina (1995 – 1996)

Oral Solid dose Contract Manufacturing Supervisor

Culligan Water Conditioning, Naugatuck Connecticut (1993 –1994)

Residential water conditioning system sales.

Boehringer Ingelheim Inc. Danbury Connecticut (1980 – 1992)

Oral Solid dose Manufacturing Technician, Team Leader and Supervisor.

Professional Certifications and Affiliations

Charter member of the NC Bionetwork Pharmaceutical Advisory board which focused on NC economic development through effective marketing of NC workforce development.

Recipient of the North Carolina Community College Systems BioNetwork 2008 Person of the Year award.

Contributing member of the NC process technician job analysis panel which revised the existing skill set requirements for minimally competent technicians in the Biotech industry.

NC Bionetwork/ Durham Technical Community College PharmaWork classroom training participant certification.

Past President 2008-2014 of the Southeast Chapter of GMPTEA (Good Manufacturing Practices Training and Education Association).

Member of the Durham Technical Community College Corporate Education advisory committee.

Current Durham Technical Community College part time staff member. Teach instructor lead sessions on GMP Orientation/Refresher, GMP Deliberate Documentation, GMP Conducting Investigations to BioNetwork students.

ISPE GMP Certified Auditor May 2006 (Past member of Eisai Inc internal audit team)

Education:

Western Connecticut University (Business Management) / 30 Credits

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