Quality Assurance Specialist
Resume:
Jose Ariel de Jesus
**************@*****.***
Experience
Professional with strong experience in Quality Assurance Incoming Tests, Warehouse management, Manufacturing Process and Environmental Control in the Pharmaceutical Industry. Broad experience on multifunctional teams with suppliers to improve components quality and supply. Lead incoming area trainer for new colleagues. Lean Six Sigma Yellow Belt Certified. Strong experience in organization transformation efforts toward efficiency, productivity and quality. Plant Subject Matter Expert (SME) on all issues related to components statistical sampling, proofreading and disposition.
Quality Assurance Analyst
Phoenix Packaging Operations 2014- Actually
•Ensure that the standards of excellence are maintain during the production of plastic and foil components.
•Perform inspections at all stages of production, including reviews of raw materials, manufactured components, finish products and documents related.
•Keep the records, trends and charts of incidents.
Quality Control Specialist
Pfizer Pharmaceutical, Carolina, Puerto Rico (Formerly Wyeth) 1998 – 2012
•Complete Event Report Notification and/or Quality Event Report to investigate and implement CAPAs for defective components, process deviations and non-conformance.
•Perform physical, dimensional and visual evaluation of production components.
•Responsible for Quality Assurance disposition of filling, sealing, medical devices and packaging components. Proofreading of art work and printed material, sampling raw materials, bulk, cGMP’s monitoring, safety audits, shipping process, and controlled substances handling.
•Responsible to keep up date the calibration of the equipment, issue purchase orders of new equipment and supplies.
•Maintain trend reports on visual inspection for particulate matter, vial defects, complaints and observation reports to supplier, spot checks, and retention samples inspection.
Aseptic area employee
Wyeth Ayerst Pharmaceutical, Inc., Carolina, Puerto Rico (Formerly Lederle) 1995 – 1998
•Held multiple positions in manufacturing operations such as: sanitation of the aseptic complex, filling operator, freeze drying operator, formulation specialist, sealing operator, equipment preparation and packaging.
Quality Control Inspector
Lederle American Cyanamid Pharmaceuticals 1990 – 1995
•Responsible of perform sampling and statistical inspection to define the quality of manufacturing components.
•Sampling raw material to send samples for external laboratories.
•Responsible to perform proofreading to printed material according specifications.
• Sampling and handling controlled substances, according to SOP’s and DEA regulations.
•Performed chemical tests for tubing vials as sulfur test, coring and flake tests to filling components.
Skills
ANSI Statistical sampling (AQL) SME for production components, medical devices, raw materials (including biological, toxic and non-toxic materials), Controlled Substances Management, take and monitoring water samples, Inventory Management and critical processing aids (CPA) evaluation and disposition. Co-Author of SOPs and Job Aids for defects evaluation, interpretation drawings and review of historical data for material/product acceptance criteria. Computer literate in the following software’s: Microsoft Word, Excel, PowerPoint, LIMS, LACES LABWARE, SAP, GPS, QALASS (controlled forms system). Use of electronic calipers, ISOLATOR, Mitutoyo DPX 1 and DPX 3, Deltronic and Mitutoyo Optical Comparators, top loader balance, METO 8300 and DATAMAX label machines.
Education
BD Business Administration
Universidad Metropolitana, Ana G. Mendez Foundation, Rio Piedras, Puerto Rico.
Naturals Sciences and Environmental Courses
Universidad del Este, Ana G. Mendez Foundation, Carolina, Puerto Rico
AD Industrial Chemical Engineering
Instituto Tecnologico de San Juan, Rio Piedras, Puerto Rico
Accomplishments
•Supported and implemented of Lean Six Sigma Kaisen project in Incoming area resulting in significant sampling time and cost reduction.
•Established of alliances with key components Suppliers to develop common understanding, practices and procedures of quality standards for tubing and molded glass, aluminum seals, stoppers, printed materials and corrugated carton.
•Performed a catalog of physical defects for molded and tubing glass vials, stoppers and aluminum seals; as per aseptic manufacturing requirements.
Trainings
CGMP’s, Toxic Material Handling, Aseptic filling, Supplier Certification, Fire Prevention, Controlled Substance disposition and storage, Use of Dust and vapor respirators, Forklift Operations, Hand truck, Counter Balance, Aerial platform Operation, (licensed), TQM, OSHA, DEA,FDA, AMSSCA, safety, USP, NOSH, OSHO, MSDS.
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