José L. Cruz-Ellis, BS, MT, CLS, ASQ CQA

Monte Real 1000 Box 159 San Juan, Puerto Rico 00926 787-***-**** nqzqyb@r.postjobfree.com

Summary of Qualifications

Quality Specialist with vast experience within the Pharmaceutical/Medical Device Industries, expertise in the areas of: Quality, Manufacturing & Occupational Safety. Demonstrated abilities in Management, Regulatory Compliance, Monitoring and Quality Audits. A strong scientific background in medical technology. Organized, team work and results oriented. Strong analytical and problem solving abilities. Excellent interpersonal and communication skills. Good computer skills in Microsoft Office.

Major Accomplishments

• Reduced 80% of incidents by performing safety and environmental trainings for employees.

• Selected to conduct a Quality Audit to the plant Quality Audits Department and review the master procedure with outstanding results and major savings to the organization.

• Expedited the release of Dilantin by performing a specific batch record review prior to FDA approval.

• Minimized 100% of backorders by reducing the quality of non-conformances.

• Reduced in 100% the purchased of distilled water.

• Qualified and validated a new building (Proline) before the target period.

Professional Experience

Schering-Plough Products LLC, Las Piedras, Puerto Rico

Safety Compliance Specialist / Assoc Occupational Safety Specialist 2003 – 2009

• Assisted the Safety and Environmental Manager in preparation and implementation of SOPs. Prepared Change Controls for new/ revision of procedures to Regulatory Department.

• Originated Work Orders.

• Performed regulatory audits for OSHA & GMP’s requirements and report the findings to computerized system.

• Followed up with Directors of each area for completion of findings, observations, nonconformance, incidents and others.(CAPA’s).

VTS Consultants, Westborough MA- Schering-Plough Products LLC, Las Piedras, P.R.

Validation Specialist (Consent Decree Status) 2001 – 2003

• Reviewed, updated and generated standard operating procedures (SOP’s) for all departments including Safety and Environmental, in accordance with corporate procedures.

Life Science International – Warner Lambert Inc., Fajardo, Puerto Rico 1998 – 1999

Q.A. Documentation Consultant Auditor (One year contract) - Consent Decree Status

• Performed batch records reviews, including raw materials, Dilantin Performances, Raw Data from Q.C.. Laboratory, packaging orders, formula cards, and other documents audited and certified according to the FDA regulations.

Ortho Mc Neil Johnson & Johnson, Dorado, Puerto Rico

Production Supervisor (One year contract) 1996 – 1997

• Directly supervised a staff of 40 operators of Granulation, Compression, Encapsulation, and Packaging Areas.

• Coordinated and implemented work schedules for operation. Audited and approved the reconciliation of batch records for all areas.

Zenith Pharmaceutical Corporation, Cidra, Puerto Rico

Quality Assurance Supervisor 1994 – 1996

• Supervised a staff of 18 Quality Inspectors of Manufacturing and Packaging Areas.

• Reviewed and approved the In-process inspections in order to finished products.

Ethicon Johnson & Johnson, San Lorenzo, Puerto Rico

Quality Assurance Supervisor 1991 – 1994

• Supervised a staff of 15 Quality Assurance Technicians.

• Provided support for the overall Environmental Plant Program.

• Conducted ergonomics evaluations for work stations.

Merck Sharp & Dohme, Caguas, Puerto Rico

Quality Control Auditor 1988 – 1991

• Performed audits of manufacturing and packaging areas and special investigatigations studies related to Quality Assurance.

• Directly supervised Microbiologists’ performance for water testing procedures.

• Handle customer complaints of end products and performed proper investigations and corrective actions.

Warner Lambert, Inc. Fajardo, Puerto Rico

Quality Assurance Supervisor 1985 – 1988

• Assured adequate coordination of the Analytical and Microbiology Laboratories.

• Reviewed and approved all analytical reports.

• Supervised a total staff of 10 Chemists & Microbiologists of two laboratories of the Plant.

Education

Interamerican University Metro, Rio Piedras, Puerto Rico

Post Graduated in Medical Technology Certification (MT)

University of Puerto Rico, Mayagüez Campus

Bachelor in Sciences (BS), Major in Biology and Education, minor in Chemistry

Certifications

• National Credentialing Agency for Medical Laboratory Personnel, Inc. (NCA)

• Clinical Laboratory Scientist (CLS)

• Biotechnology Certification – Advance Professional Development Center – Caguas, P.R.-2006

• ASQC – Certified Quality Auditor (CQA)-2006

• 30-hours OSHA General Industry Safety & Health Outreach-2008

• CAPA System Expert Certification by Business Excellence Consulting-SEP/2009

Licenses and Affiliations

• Puerto Rico Board of Examiners, Medical Technology (Lic. # 2347)

• American Society of Medical Technologists (ASMT)

• American Society for Quality Control (ASQC)

• American Society for Microbiologists

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