PROFESSIONAL EXPERIENCE
Zimmer Biomet, Warsaw, Indiana (01/02/18 – 11/16/18) Senior Quality Auditor
Audited the manufacturing operations to verify compliance to SOP’s and engineering standards. Coached manufacturing operators on how to respond and interact during inspections by regulatory agencies. Audited Quality Systems documents such as Preventive Maintenance, Microbiology Results and Validation of Process Parameters to ensure compliance with Standard Operating Procedures. Participated in FDA inspection of the facility performed follow up audits to some of the agency’s observations. Audited clean rooms. Audited Microbiology and Chemistry laboratories for Good Laboratory Practices. Performed Verification of Effectiveness (VoE’s) of several CAPA’s.
Cook Medical, Bloomington, Indiana (11/15/2016 – 7/25/17)
Design History File Engineer, Provide Quality Engineering support to sustaining manufacturing and remediation project teams for medical devices to ensure proper design and process development, inspection and controls, and execution of Quality System processes. Evaluate product design history gaps and manufacturing-related quality issues, implement quality improvement and remediation activities and participate in quality activities. Provide support for key deliverables through creation, review and approval for sustaining products; verifications/ validations/qualifications plans, protocols, testing, reports, including nonconformance investigations and CAPA resolution.
Responsible for the remediation of Design files for the Flexor and Performer Introducers. Following the approved remediation protocol, created the MDF Change requests, generated a list of reportable complaints for the last 5 years utilizing TrackWise and produced the Clinical Evaluation Analysis and the Design and Process Trace Tables to determine the possible gaps in design and process controls. Using that information remediated the gaps identified.
CAPA Coach SME
Investigate product and process CAPAs remediation. In charge identification, segregation, investigation, root cause determination, implementation and verification of product and process CAPAs to remediate systemic gaps in the Quality System. Identify corrections to quality issues, investigation of the problems and root cause determination using tools such as SIPOC Diagrams, 5 Whys, Fishbone diagrams and IS/ IS NOT analysis. After root cause identification, implement planned actions to correct systemic actions to address corrective actions, finally verify the effectiveness of the actions.
Biomet 3i, Palm Beach Gardens, Florida (04/2015- July 2016)
Investigated and documented non-conformances utilizing Tip QA, Process Failure Mode and Criticality Analysis (PFMECA), CAPA request and Document Change Request. Reported to the Plant Quality Manager.
Maquet Cardiovascular, Wayne, New Jersey (10/ 2014- 03/2015)
Consultant
Customer complaints remediation at Maquet Cardiovascular in Wayne, New Jersey. Responsible for the complaint intake, evaluation, investigation and closure of the customer complaints process. Familiar with MDR reportability, decision trees and failure mode. Handled the Intake of over 200 complaints for Intra Aortic Balloon Pumps.
Abbott Medical Optics, Añasco, Puerto Rico (04/14- 08/14)
Senior Quality Consultant
Responsible for the CAPA and NCR Remediation Project in the area of Pest Control. The objective of this project was to make sure the high risk CAPAs were ready to withstand the scrutiny of an audit from a regulatory agency. Performed gap analysis and ensured that the CAPAS and NCRs were in alignment with internal SOP’s, GMPs, and GDPs. Used a CAPA and NCR rubric to accomplish this. Updated weekly the Project Manager on CAPAs and NCRs status. Served as liaison between the facilities department and QA to ensure a timely completion of CAPAs and NCRs. Responsible for presenting and defending CAPAs in the CAPA Review Boards weekly meetings. Responsible for coaching and training key operational players in the proper way to write CAPAs.
Merck Manufacturing Corp, Miami, FL. (10/96 – 12/13)
During this time have held different positions within the organization including Production Supervisor (1996-1998), Quality Specialist(1999- 2001) and Quality Auditor (2001- 2013)
Production Supervisor (1996 - 1998)
I coordinated on a daily basis the manufacturing and packaging operations for Cedax and Nitro-Dur. Assure that the manufacturing and packaging operations are performed on a timely basis following the GMP’s and within the time standards. Informs Quality of non conformance events, coordinate corrective actions and closure of NOE’s (Notice of Events) and assigns CAPA’s as necessary. Participates in the daily production meetings to brief other departments on schedule completion status, identify need for support from other departments and coordinate with maintenance/ engineering repairs and preventive maintenance for the equipment. Participates in the release of the lines at the beginning of each lot. I was responsible for the yearly performance evaluation of the manufacturing and packaging operators and line leaders. Identify opportunities for reduction of time and material waste to continuously improve the operation.
- Supervised thirty three hourly operators and four Line leaders in the manufacturing, Coating, Slitting, Lamination and packaging of transdermal products (Nitro-Dur)
- Supervised seventeen operators in the Pharmacy, Blending, Encapsulation, Banding and Packaging of solid dosage capsules and suspension products.(Cedax)
- Extensive experience with notice of events, variance investigations and corrective action/ preventive actions (CAPA’s) determination
Quality Specialist (1999 - 2001)
Responsible for the release Manufacturing and Packaging Lines . Inspects the packaging lines and manufacturing rooms before the lot starts and assures all release criteria are met. Communicates with production when a non conformance event takes place. Advises production in the appropriate corrective actions. Verify the corrective actions are performed in accordance with applicable Standard Operating Procedures. Resamples the product using Military Standard 105E to assure the effectiveness of the corrective action. Verify that the root cause was identified and addressed before authorizing continuation of the lot.
- Experienced in line release and line audits in the manufacturing and packaging process
- Proficient in defect classification and corrective actions
- Extensive knowledge of Military Standard sampling methods
Quality Auditor (2001 - 2013)
Responsible for the documentation review and release in relation to manufacturing in process, raw materials, packaging components and finished goods. Ensures that all documentation follows good manufacturing practices, good documentation practices and good laboratory practices. Participates in the daily production meetings(Tier 2) meetings. Updates management on lot releases. Assist production with corrective actions and completion of Notices of events. Performs periodic quality monitoring of the production, packaging and warehouse facilities to determine compliance with cleanliness and, housekeeping, GMP’s and calibration requirements.
- Complied with FDA and GMP requirements for batch record reviews included in all phases of product release.
- Reviewed all quality-related documentation for adherence to cGMP, cGLP, and SOP.
- Initiated investigations and discrepancies reports when a batch failed to meet specifications.
- Closed Investigations and Notice of Events using TrackWise
- Opened and closed CAPAs using TrackWise
- Experienced in the use of root cause analysis tools such as Fishbone Analysis, Five whys, Pareto Analysis and Gap Analysis
- Conducted training and qualification for other Product Release Auditors.
- Performed the reviewing and writing of Standard Operating Procedures through Global Electronic Document Management System (GEDMS).
- Responsible for documentation/record control.
- Familiar with TrackWise®, Documentum and change controls.
- Determined the release, reject, or conditional release of a batch.
- Participates regularly in Production meeting and an provides weekly lot status reports
- Performed all duties in a timely manner, adhering to all Company’s safety and operating policies and procedures.
ADDITIONAL EXPERIENCE
Telectronics Pacing Systems, Miami FL
Validation Engineer (Consultant)
Authored the Validation Requirement for the induction sealer
Authored the IQ/ OQ protocol for the Induction sealer
Authored the OQ protocol for the Brazing process
Analyzed data and put together reports as needed
Schein Pharmaceuticals, Puerto Rico
Validation Engineer (Consultant)
Successfully completed the qualification of the Solid Dosage packaging line including bottle cleaner, Merrill Filler, cottoner, Lakso capper , Jones cartoner, labeler and case packer.
Qualification of the water system
Qualification of the MG2 encapsulator
Mova Pharmaceuticals, Puerto Rico
Manufacturing Supervisor
During that time held the position of Manufacturing supervisor and Validation Engineer
Participated in the successful transfer of Lopressor
Participated in the experimental and validation batches
Supervised 15 employees and two group leaders in the pharmacy, granulation, blending, compression and tablet coating areas
Experienced with V blenders, Manesty tablet compressors, Glatt granulators and Vector coater
Experienced in goal setting and performance evaluations
Proficient in variance reports and process investigations
Experienced in labor variance investigations
Saved over $200K/ year by a project consisting of standardizing the containers for optimization of warehouse space
Participated in the experimental lots and process validation for Naproxen Sodium
Participated in the process optimization for Levo-T
Pfizer Corporation. Puerto Rico
During this time held the positions of Packaging Supervisor and Production Supervisor
Supervised 20 packaging operators and one line leader
Supervised the blister filling for Loestrin using the Hassia and Kloeckner fillers
Experienced with potent drug areas gowning and de- gowning
Supervised the wet granulation, milling and compression of Loestrin
Experienced with pellet coating of Erytromycin (Eric)
Experienced with Benadryl encapsulation and Banding
EDUCATION
Master in Business Administration (Magna Cum Laude)
University of Phoenix, 1989
Bachelor of Science in Industrial Engineering (Magna Cum Laude)
Polytechnic University of Puerto Rico
COURSES AND TRAININGS
Problem Analysis and Solution process
Time Management
Continue Improvement process
Computer literate
Bilingual (fully proficient in English and Spanish)
Basic Course for granulation and solid dosage pharmaceutical manufacturing
Performance Evaluations and Goal Setting
Coating workshop at Glatt headquarters in New Jersey
Certified Yellow Belt
Lean Manufacturing
REFERENCES AND SALARY HISTORY
Will be provided upon request