BS Industrial Microbiology
Resume:
Mariela Cruz Vélez
Gibsonton Fl 33534
Email: acwelf@r.postjobfree.com
Professional Summary:
Experience in working with Providers related to Medicare Health Plans. Professional experience in Quality Operations Areas (Quality Control and Regulatory Compliance) within a pharmaceutical environment under an FDA Consent Decree.
Experienced in Contracting and Provider Services in Health Plans, Quality Systems, Microbiology, Customer Complaints handling, Investigations, Corrective and Preventive Actions, Stability and Annual Product Review.
Knowledge in cGMP’s and Trackwise Systems for Customer Complaints, Change Authorizations, Notice of Events, Deviation Investigations and Corrective / Preventive Action Modules.
Knowledge of Microsoft Office (Word, Excel and Power Point).
Bilingual (English and Spanish).
Certified as a Train of Trainer.
Demonstrated to be committed with the company goals.
Dynamic and fast learner.
Self-starter and teamwork oriented.
Excellent communication, organizational and interpersonal skills.
Collaborated to the cGMP’s Certification of a pharmaceutical plant.
Supported the improvements for the Complaint area to achieved goals.
Professional Experience:
MSO of PR, LLC 2014-2016
IPA PCP Executive
Perform visits to Primary Care Physicians within an IPA and Specialists in the North Area of PR for contracting process, service and trainings of different MSO iniciatives, like for example Model of Care, Annual Health Assessments, Preauthorizations, Referrals, Home Advantage Program, 5 Star Program, Reports (Quality, Improvement, Financial).
Experience with different type of contracts (Capitation Models, Fee For Services, Flat Fee, and strategic contracts.
Train Physicians and their personnel in ICD-10 Certification.
MSO of PR, LLC 2014
Contracting and Provider Relations Representative
Perform visits to Specialists, Hospitals and Ancillary facilities in the Northwest Region of PR for contracting process, service and trainings.
Ensure that the provider uses Innovamd applications in order to comply with the company goals.
Assist providers in any issue that is needed regarding credentialing, recredentialing, claims, payments or other issues.
Knowledge in QNXT, Onbase, Netcom, and Medhok.
MSO of PR, Inc 2009-2014
Hospital and Ancillary Provider Service Representative
Perform visits to Hospitals and Ancillary facilities (Emergency Rooms, Urgent Care, Ambulatory Clinics, Clinical Laboratories, Radiology Facilites, Ambulances, and Durable Equipment Facilities, in the Northwest and Southwest Regions to give orientations and provide service and contracts assistance.
Perform facility inspections (Emergency Room / Radiology Centers).
Give Hospital Orientations regarded to MMM / PMC Product Benefits.
Participated in the Recontracting of laboratories, ambulances, TNPR among other specialties.
Complete InnovaMD Platform enrollment of providers.
Coordinates activities and trainings and assists to meetings.
MMM Healthcare, Inc. 2007-2009
Provider Service Representative
Perform visits to Primary Care Physicians and Specialists in the Northwest Region of PR to give orientations and help them to resolve their situations related to MMM Healthcare and PMC Medicare Choice.
Perform reports to document daily results.
Give support to different special projects of the company related to the improvement of the Providers service.
Schering Plough Products, LLC. Manatí, P.R. 2004-2006
Stability / APR and Customer Complaints Specialist
Handle Product Quality Complaints and Adverse Event Complaint Investigations from customer complaints regarded to marketed products.
Communicate effectively with other departments.
Perform Batch Record Reviews and evaluation of returned samples.
Preparation of weekly metric reports and monthly trends.
Performance of self-inspection audits and handling of CAPAs.
Completion of Annual Product Reviews.
Support the Stability Area performing visual inspections, Implementation of Stability Sampling Plans and reviewing Stability Annual Reports.
Accomplishments:
Collaborated to the cGMP’s certification of the Plant having cero human errors and completing satisfactorily and in most cases before the target dates each of the tasks that I was responsible for.
Reduced by 50 % the timelines for the Product Quality Complaints.
Completed 90 % of the Customer Complaint Investigations before the target date.
Biologist I 2002-2004
Performed the following Microbiological Testing: Water (Total Count and Coliforms) with Pour Plate and Membrane Filtration methods; Limulus Amebocyte Lysate (LAL) for water, Bulk, Raw Material and Finished Products; Swab, Bioburden, Biological Indicators and Antimicrobial Effectiveness.
Training and qualification of personnel in every testing that I performed.
Execution of protocols, Interpretation of results and Trend graphics.
Handled Variance and OOS laboratory investigations.
Generated documentation upon the request of the FDA regarded to regulatory inspections.
Education:
U.P.R. Mayaguez Campus, Mayaguez P.R.
B.S., Industrial Microbiology, graduated with honors.
Affiliations:
Member of the Student Association of Industrial Microbiology (SEMI).
Training:
ICD-10 Specialist Certification
True Colors
Advanced age people perfil
Increasing your productivity
Root Cause Analysis
Technical Writing Skills in English
Attention to Detail
Right First Time (RFT) / Supply Improvement Process (SIP)
Kepner and Tregoe
Refferences:
Available upon request
Contact this candidate