MELVIN COLON-DONATO

Mobile: 787-***-****

Home: 787-***-****

acb12j@r.postjobfree.com

SENIOR QUALITY ASSURANCE AND COMPLIANCE PROFILE

A licensed Chemist professional with over 16 years of a progressive record of success in the pharmaceutical, biotechnology and medical devices industries. Experienced in Quality Assurance Management, Quality Control, Quality Systems, Validation, Regulatory Compliance, Risk Assessments, Manufacturing Operations, Project Management, Supplier Quality Management, Documentation Control, Electronic Batch Records, Medical Devices and Quality Engineering.

PROFESSIONAL HIGHLIGHTS

* Mentor site management in a Consent Decree Environment resulting in cero observations and Successfully lead and delivered steps related to Consent Decree

* Prepared the sites for regulatory inspections and led regulatory inspections resulting in cero observations

* Lead efforts to ensure successful implementation of new quality systems

* Managed the transference of Analytical Methods

* Successfully managed resources and personnel and leadership of Technical Quality Teams and Validation Projects

* Manage multi-million-dollar project budgets with cost savings

* Capable of leading remediation projects in a Consent Decree environment as a QA Lead

* Able to implement and efficiently complete heightened sampling systems for Raw Materials and Packaging Components as part of a regulatory commitment

* Efficient in creating corporate level CAPA Systems that achieve the dismissal of any finding letters.

* Qualified to develop and review regulatory documents for the submission of new products or revision of products such as CTD and documents related to pre-approval inspections

* Inventive in generating and implementing an investigation system based on DMAIC approach, providing improved results on internal and external audits

* Competent in leading cohesive investigation review boards composed of upper management and Subject Matter Experts to inquire about problem root causes

* Experienced in LIMS, Empower, TrackWise, SAP, Minitab and Applied Statistics, GxPharma,and MES

PROFESSIONAL CONSULTING EXPERIENCE

2012 – 2013 Consent Decree QA/GMP Expert, McNeil Consumer Products, Las Piedras, PR

This site under a Consent Decree.

* Act as the liaison between site management and third-party contracting firms

* Participate in Risk Assessment Meetings/FMEA as QA responsible

* Responsible for auditing and approving documents related to the work stream

* Responsible to perform audits

2011 – 2012 Consent Decree Quality Assurance Lead, Genzyme, Allston, MA

This site under a Consent Decree.

* Oversee and provide regulatory guidance during the Project Strategy, Change Controls, and Validation Master Plan development processes.

* Responsible for the review and approval of validation documentation (Design Qualification, FAT, SAT, Commissioning, Protocols IQ, OQ, PQ and Reports), SOP, Change Controls, Investigations, among others.

* Act as the liaison between site management and third-party contracting firms.

* Ensure Quality Systems are effective and reliable.

* Performed and Reviewed Gap Assessments

* Successfully managed QA Specialists

* Represented the QA team in status meeting, provide status and metrics to Site Management.

* Revised and generated Site Validations SOPs

* Participated as QA SME during the external verification process

2011 Senior Quality Assurance Supervisor, McNeil, Las Piedras, PR

Site under a Consent Decree.

* Performed internal audits and presented findings to QA Management.

* Responsible for the review of Investigation Reports.

* Managed Quality Technicians

2009 – 2011 Quality Assurance Project Manager, Bristol Myers Squibb, Humacao, PR

* Assured regulatory document met BMS requirements and stakeholder interests through the implementation of Six Sigma (DMAIC) approach.

* Performed Internal Audits, developed quality event investigations and prepared quality technical assessment reports.

* Evaluated, investigated, and responded to customer complaints.

* Identified quality process gaps and provide compliance evaluations to narrow gaps.

* Managed and implemented PAT (Process Analytical Technology) in QA/QC departments in order to track and control manufacturing processes. Revised and approved Validation Protocols related to PAT manufacturing process and method validation.

* Prepared the site for the Pre-Approval Inspection and Regulatory Agencies inspections (EMEA, FDA), among others.

* Prepared responses to internal and external observations (483).

* Revised and generated SOP related to PAT, batch records reviews, trending and others.

* Created Common Technical Document (Module 3) for the introduction of a new product.

2009 Quality Flow Improver, Pfizer, Caguas, PR

* Developed investigation reports due to failures during packaging and manufacturing process.

* Created and managed CAPA’s. Reviewed cleaning trends and developed cleaning validations for packaging lines and manufacturing processes. Reviewed SOP’s and trained operators.

* Responded to customer complaints in order to maintain excellent client relations.

2009 Quality Assurance Consultant, Sandoz, Wilson, NC

Site with Warning Letter

* Audited quality systems to include preventive maintenance, calibrations, validations, change controls, work orders and SOP’s. Evaluated findings and provided guidance to resolve FDA observations.

* Developed training materials and conducted training with personnel in GDP’s.

2008 Quality Assurance Consultant, Teleflex Medical, PA, and Arlington Heights, IL

Sites with Warning Letter, Medical device Class I and II

* Quality Assurance Consultant

Audited quality systems including CAPA’s, Non-Conformances, and complaints. Provided feedback from Compliance’s point-of-view to Quality Systems. Evaluated CAPA’s, Non-Conformances and complaints to assure compliance. Presented to MRB findings and resolutions as to the audit performed. Implemented a new CAPA system.

* Project Manager

Managed the audit of the Illinois site. Managed gap assessment audit of quality systems, development of equipment list, product list, gap assessment for validations performed during previous three years, process mapping and risk assessment. Managed Remediation activities.

2007 Project Manager, Becton and Dickinson, Juncos, PR Medical Device Class I and II

* Managed the transference of molds and moldings validation from different suppliers to a new supplier. Monitored and served as a liaison between the new suppliers, BD, and old suppliers.

* Developed strategies and managed last article inspection metrology and first article inspection metrology.

* Managed and coordinated validation activities and closing of validation reports. Managed timelines, resources, metrics, and budget.

2005 – 2007 Quality Assurance Consultant, Wyeth, Guayama, PR

Site with Warning Letter

* Reviewed and approved change controls of QA/QC, technical services, engineering, IS analytical laboratory, microbiological laboratory and manufacturing areas.

* Reviewed and approved validation documentation of all areas (Facilities, Utilities, LIMS, IS, QC Labs, Packaging, and PAT).

* Reviewed quality systems and provided guidance to be under compliance. Reviewed Master Validation Plan.

* Provided support to change the CSV and validation approach for the implementation of a new policy. Managed computer room and infrastructure project.

* Managed QA projects and served as a liaison between the QA department and other departments.

* Developed and maintained project plans, timelines and resources. Facilitated the implementation of different projects against the manufacturing site.

* Provided support and assistance to the site as a consultant providing ideas and recommendations to be in compliance with laboratories, QA and engineering areas, as well as support in LIMS and LACE’s area with the review and documentation approval.

* Provided feedback and support to the implementation of IS procedures for system security and control, access security, preventive maintenance, disaster recovery and operations controls. Implemented IS procedures for system security and control, access security, preventive maintenance, disaster recovery and operations controls.

EDUCATION

Master of Science in Manufacturing Competitiveness, Polytechnic University of Puerto Rico, Hato Rey, PR

Thesis: “Leverage from FAT, SAT and Commissioning into Qualifications Using a Filler of a Packaging Line as a Model in the Pharmaceutical Industry”

Master Engineering Management, Concentration in Pharmaceuticals Management, Polytechnic University Of Puerto Rico, Hato Rey, P.R.

Bachelor in Science, Industrial Chemistry, University Of Puerto Rico, Humacao Campus, Humacao, PR

YEARS IN THE INDUSTRY: Sixteen (16)

TECHNICAL EXPERTISE

* Analytical Chemistry

* Environmental Monitoring

* FMEA Processes

* Method Qualifications

* Equipment Validation

* Non-conformance Investigations

* Facilities Qualifications

* Failure Investigations/Gap

* Analysis Cleaning Validation

* Clean-In-Place (CIP)/ SIP

* Computer Validation

* Lyophilization Processes

IT/ AUTOMATION:

* TrackWise

* SAP

* Windows

* Compliance Wire

* EDGM

TRAINING

* Certified Quality Auditor Academy (CQA)

* Corrective and Preventive Action Certification (CAPA)

* Project Management Certification Training (PMP)

* Deviation Investigations

* Handling FDA Inspections

Pre-2005 Additional Selected Contractual Projects

* Quality Assurance Consultant, Pfizer Pharmaceuticals, Terre Haute, IN

* Validation Consultant, Site under Consent Decree, Glaxo Smithkline, Cidra, PR

* Project Manager, Cordis Llc, San German, PR, Medical Device Class III

* Validation Consultant, Bristol Myers Squibb, Syracuse, NY

* Project Manager, Pfizer Pharmaceuticals, Caguas, PR

* Validation Consultant, McNeil Consumer Products, Las Piedras, PR, Cardinal Health, Humacao, PR, Merck, Barceloneta, PR, Watson Laboratories, Humacao, PR

Previous Permanent Experiences:

* Lead Validation Specialist, Foth & Van Dyke, Guaynabo, PR

* Process Specialist, Pharmacia, Caguas, PR

* Compliance Analyst, Pharmacia, Caguas, PR

* Laboratory Analyst, Pharmacia, Caguas, PR

* Laboratory Analyst, McNeil Consumer Products, Las Piedras, PR

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