Melvin Colón, Mem, Msmc's Location
United States, United States
Melvin Colón, Mem, Msmc's Contact Details
Melvin Colón, Mem, Msmc work email
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Melvin Colón, Mem, Msmc personal email
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About Melvin Colón, Mem, Msmc
I am a dedicated Quality Assurance Consultancy Leader and a licensed Chemist with over 20 years of rich experience in the pharmaceutical, biotechnology, and medical devices sectors. My passion lies in elevating the standards of quality assurance and compliance, leveraging my deep expertise and innovative approaches to foster excellence across diverse product lines.Throughout my career, I have specialized in leading comprehensive quality assurance (QA) and quality control (QC) initiatives, ensuring that all products not only meet but exceed the rigorous regulatory compliance standards set by authorities. My work encompasses a broad spectrum of activities, from developing and implementing robust QA/QC systems, conducting meticulous audits and inspections, to engaging in continuous improvement processes that enhance product quality and safety.My approach to quality assurance is holistic and data-driven. I believe in harnessing the power of cutting-edge technologies and methodologies to streamline processes, reduce errors, and ultimately, deliver products that are of the highest quality and safety standards. This commitment to excellence has been the cornerstone of my career, allowing me to successfully navigate the complex landscapes of the pharmaceutical, biotechnology, and medical devices industries.I am also a firm advocate for collaboration and knowledge sharing, understanding that the best outcomes are achieved when teams work together towards a common goal. Through effective leadership and mentorship, I have built and guided high-performing teams that are equally committed to the mission of ensuring product integrity and compliance.In summary, my career is driven by a singular vision: to elevate the standards of quality assurance and compliance through expertise, innovation, and leadership. I am always keen to connect with like-minded professionals, share insights, and explore new opportunities that will further advance the field of quality assurance in the health sciences industry.Let's connect and make a difference together!
Melvin Colón, Mem, Msmc Work Experience Details
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Sr. Qa ConsultantAlvotechUnited States -
Sr. Qa ConsultantThe Fda Group Nov 2024 - PresentWestborough, Ma, Us -
Sr. Qa ConsultantHenrici Group May 2024 - PresentNew York, New York, UsPerformed DI assessment of client’s manufacturing and QC processes. Performed the gap assessment of the Deviation, CAPA, OOS SOPs, complaints investigations, process validation protocols, and packaging validation. Assessed OOS and deviations of products in expiry. Cambridge, MA Performed the review of Common Technical Document Module 3 for compliance and Data Integrity. -
Sr. Qa ConsultantLife Sciences And Technology Consulting Jan 2024 - PresentPerformed a Data Integrity evaluation of the Common Technical Document of ANDAs submitted and the new ANDA to be submitted to the US FDA.
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Sr. Quality Assurance ConsultantNatco Pharma Jul 2024 - Aug 2024Hyderabad, Telangana, InPerform QC Analytical batch record certification, including reviewing and assessing incidents and OOS. -
Quality Assurance ConsultantAnobri Oct 2023 - Dec 2023Performed MOCK audit, prepared the site for an FDA Pre-approval Inspection, Led the backroom during FDA inspection, and supported the site in writing FDA regulatory observations.
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Quality Assurance LeadThe Luttrell Group Feb 2023 - Oct 2023Lead MODA-EM implementation; Responsible for the issuance of the Environmental Monitoring trend reports, Site Readiness and Lead backroom activities during Biological License Application audit (EMA and FDA)
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Quality Assurance ConsultantHenrici Group May 2023 - Jul 2023New York, New York, UsPerformed a Data Integrity Assessment of cleaning procedures and forms.
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Sr. Compliance EngineerMcd Consulting Services Jan 2023 - May 2023Provided coaching and GxP Guidance. Performed GMP Audit and Gap Assessment, GMP Training, Reviewed and Rewrote SOPs, Issued Engineering Investigations, Issued and closured of CAPA, Wrote and supported Change Control completion against current FDA regulations and current guidance documents and/or remediation, implementation, including training, and subsequent monitoring of the system.
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Sr. Qa ConsultantHenrici Group Nov 2022 - Jan 2023New York, New York, UsPerformed a Data Integrity Gap Assessment of the purified water system and defined the corrective actions to be taken.
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Head Of Quality AssuranceBuoyant Pharma & Device Manufacturers Jul 2022 - Oct 2022Responsible for the recruitment, development, and day-to-day management of Quality resources required to perform the pharmaceutical site start-up plan. Led design, development, and implementation of quality policies and procedures to meet work plan requirements. Represented the site during FDA inspections.
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Qa LeadLuttrell Group Jul 2021 - Jul 2022Support the transaction from clinical to commercial manufacturing. Lead the Document and Label Control Remediation Workstream. Lead Label Software (BarTender) and Document Management System Implementation (MasterControl). Lead Batch Production Record, and SOPs improvement initiatives including the Quality Manual.
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Sr. Qa ConsultantMcd Consulting Services Jan 2022 - Mar 2022Support API Start-up. Provide guidance for Quality System Implementation.
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Sr. Qa ConsultantThe Gintegra Group Aug 2020 - Feb 2022Perform Batch Record Certification (Sterile Process) which included the review of all associated COA, Analytical Raw Data, Lab and Manufacturing Investigations, Manufacturing and Packaging process.
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Qa LeadJi Solutions May 2021 - Jul 2021Lead the review of backlog Manufacturing and Packaging records and CAPAs. Reviewed and approved manufacturing investigations. Performed assessment of the batch record review process and lead the remediation activities.
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Project Manager5Ws Consulting Jan 2021 - May 2021Richmond, Va, UsManage the review of GMP documents associated with the construction of a new facility. The documents included are: SOPs, Change Controls, and Qualification Protocols. -
Sr. Qa Consultant5Ws Consulting Jun 2020 - Dec 2020Richmond, Va, UsPerformed gap assessment on OOS and OOT investigations. Managed the Site Remediation and the Batch Record Certification Project.
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Sr. Qa ConsultantQuality Executive Partners, Inc. (Qxp) Aug 2020 - Oct 2020Atlanta, Ga, UsPerformed Facilities and Utilities Baseline Assessment. Provided guidance to QC Lab on OOS and OOT investigations. -
Sr Qa ConsultantOperations & Quality Systems Improvement Experts (Oqsie) Mar 2020 - Jul 2020Irvine, California, UsLead consultants performing the Laboratory Analytical Data and Laboratory Investigations prospective and retrospective review process. Communicate findings to client management and lead remediation activities. -
Sr Qa Consultant5Ws Consulting Dec 2019 - Mar 2020Richmond, Va, UsResponsible for reviewing and assessing analytical methods validation, similarity testing, release, and stability data for a new Biosimilar drug.
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Sr Qa. ConsultantCompounding Site Oct 2019 - Dec 2019Performed a gap assessment of the Change Control and Validation Quality Systems, developed a mitigation plan, and a remediation plan, guided management on how to accomplish the project. Act as QA responsible person by reviewing and approving all documentation generated on the remediation activities. Coached management on how to avoid the recurrence of the gaps identified.
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Remediation Project ManagerConsulting Opportunity Combination Product Site Feb 2018 - Oct 2019February 2018 – April 2018Lead the remediation of the Vendor Management Program work stream. Remediation included SOP remediation, gap assessment to current quality agreements, and assessment of all vendors/suppliers to ensure they meet new requirements. Review Quality Agreements with Vendors, Lead Suppliers Investigations, Supplier Quality Oversight (Coach Lead Auditors, Scheduling, vendor audits).April 2018- June 2018Lead Internal Audit Program. Provide guidance to internal auditors. Develop audit schedule. Perform internal audits as lead auditor to systems and subsystems including scheduled walkthrough. Issue audit reports. Track commitments upon completion and provide guidance to stakeholders.June 2018 - PresentLead the CAPA Effectiveness Check and Remediation activities related to the regulatory observations.
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Senior Qa ConsultantDietary Supplement Site Jun 2016 - Apr 2018Assessed Quality Systems vs. Internal Quality Standards and Dietary Supplement Regulations and lead remediation activities. Implemented Quality System, coach QA Management on regulatory requirements, and help the site change their Quality Culture. Improved Quality Systems by developing SOPs required and revising existing SOPs. Mentor and train site personnel on how to write SOPs, Change Control, among other Quality Systems.Lead the implementation of the C&Q program.
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Qa LeadGk Regulatory Compliance Oct 2015 - Mar 2016Lead the Quality System implementation at the new Brazil site by assessing the GMP activities to be held at the site, developing a project plan, and lead the implementation of the plan. Some of the activities included the managing Senior QA Specialists, the review and approval of Policies, SOPs, Validation Documents (qualification of the facility, utilities, equipment, Laboratory instruments).
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Principal ScientistBiotech Company Jun 2015 - Oct 2015Establish validation engineering policies for a major segment of the company. Interpret, execute, and/or recommend modifications to company-wide policies. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity. Lead efforts with manufacturing, process development, utilities, facilities, labs, and /or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Provide expert validation knowledge (equipment qualification, cleaning, sterilization). Provide technical validation solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel.
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C&Q Qa Specialist (Consultant Through Bes Consulting Services)Biotech Company Apr 2015 - Jun 2015Responsible for the review and approval of Commissioning and Qualification protocols of the expansion project.
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Qa Gmp ExpertPharmaceutical Company Jan 2015 - Mar 2015PkProvide GMP guidance during the installation of new packaging lines, cleaning remediation, process validation, packaging process validation, among other GMP activities. Activities included the review and approval of GMP documents such as Packaging Commissioning and Qualification Documents, Process Validation Protocols, Cleaning Validation protocols, Nonconformance, Change Control, Calibration, Preventive Maintenance, Deviations, among others. -
Consent Decree Qa Gmp ExpertPharmaceutical Company Oct 2012 - Mar 2015PkSite Under Consent DecreeOversee and provide regulatory guidance and mentoring to site management and Consent Decree TeamsLead External verification Process Act as the liaison between site management and third-party contracting firms. Participate in Risk Assessment Meetings as QA responsible (Q9)Responsible for auditing documents related to the work stream Led regulatory and confirmation inspections
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Consent Decree Qa LeadBiotech Company Nov 2011 - Sep 2012Site Under Consent DecreeParticipated as QA SME during the external verification process.Act as the liaison between site management and third-party contracting firms. Ensure Quality Systems are effective and reliable.Oversee and provide regulatory guidance during the Project Strategy, Change Controls and Validation Master Plan development processes.Performed and Reviewed Gap AssessmentsResponsible 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.Successfully managed QA SpecialistsRepresented the QA team in status meeting, provide status and metrics to Site Management.
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Senior Quality Assurance SupervisorPharmaceutical Company Sep 2011 - Nov 2011Site Under Consent DecreePerformed internal audits and presented findings to QA Management.Responsible for the review of Investigation Reports.
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Quality And Compliance ConsultantPharmaceutical Company Aug 2009 - Aug 2011Manage the implementation of PAT Initiative in the QA/QC department (Q8, Q9, Q10).Evaluate and develop SOP’s related to PAT process, Real Time Release, Batch Record Review, Annual Product Review, Trending, CAPA, Quality Risk Management, Tablet Defects Sampling Evaluation, LIMS, Laboratory Investigations, Internal and External Audits, and Investigation Procedure among others. Implement Six Sigma (DMAIC) approach.Train affected personnel in SOP’s.Revise and approval of Validation Protocols related to PAT manufacturing process and method validation.Perform Vendor Qualification.Create Change Control’s for Test Method Changes.Prepare the site for the Pre-Approval Inspection and Regulatory Agencies inspections (EMEA, FDA).Participate in the PAI Readiness and Inspections. Create the Common Technical Document (Module 3) for the introduction of a new product.Assure regulatory document meets BMS requirements and input from stakeholders.Perform Gap Assessment of quality processes. Develop Quality Technical Assessments Reports.Perform GMP GAP Assessments to the quality assurance, packaging, manufacturing, technology transfer, chemical and microbiology laboratories, engineering, and maintenance departments. Write responses to regulatory observations.Implement regulatory commitments.Evaluate, investigate, and respond to Customer ComplaintsPerform Annual Product Quality ReviewDevelop Quality Events InvestigationsDiscuss Quality Events Investigations in the Investigation Review BoardPerform Internal AuditsLead Investigation Status Meeting
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Quality Flow ImproverPharmaceutical Company Jun 2009 - Aug 2009Develop Investigation Reports due to failures during the packaging and manufacturing process. Create and manage CAPA’s.Investigate and respond to Customer Complaints.Review Cleaning Trends and Develop Cleaning Validations for packaging lines and manufacturing processes.Review SOP’s and Train operators.
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Qa AuditorMedical Device Company Jan 2009 - Apr 2009Audit Quality Systems such as Preventive Maintenance, Calibrations, Validations, Change Controls, Work Orders, and SOP’s. Evaluate findings and provide guidance to resolve FDA observations.Develop trainings and train personnel in GDP’s.
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Project ManagerMedical Device Company 2009 - 2009Managed the transference of several molds from different suppliers in the US to one supplier in Puerto Rico
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Quality Assurance ConsultantMedical Device Company Oct 2008 - Dec 2008Site under Warning Letter Audit Quality Systems such as CAPA’s, Non-Conformances, and Complaints. Provide feedback from compliance point of view to Quality Systems. Evaluate CAPA’s, Non-Conformances and Complaints to assure compliance. Present to MRB findings and resolutions to the audit performed. Implemented a CAPA system.
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Project ManagerMedical Device Company Jun 2008 - Oct 2008Manage the Audit of the IL site. Manage the Gap Assessment audit of the Quality Systems, development of an Equipment List, Product List, Gap Assessment to validations performed in the past 3 years, Process Mapping, and Risk Assessment. This exercise will be used to determine compliance and further actions to be taken.
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Qa SpecialistPharmaceutical Company Oct 2007 - Jan 2008PkSite under Warning Letter. Review and approval of Change Controls of QA/QC, Technical Services, Engineering, IS Analytical Laboratory, Microbiological Laboratory and Manufacturing areas. Review and approval of Validation Documentation of all areas (Facilities, Utilities, LIMS, IS, QC Labs, PAT, and Packaging). Review Quality Systems and provide guidance to be under compliance. Review of Master Validation Plan. Provide support to change the CSV and Validation approach for the implementation of a new Policy. Manage Computer Room and Infrastructure Project. Manage QA Projects; serve as a liaison between QA department and other departments. Develop and maintain Project plans, timelines and resources. Facilitate the implementation of different projects against the manufacturing site. Provide support and assistance to the site as a consultant providing ideas and recommendations to be in compliance in the laboratories, QA and Engineering areas and support in the LIMS and LACE’s Area with the review and approved the documentation. Responsible for the Installation and Operational Qualification of Hardware, Software and Infrastructure including network, computer room data center and wireless infrastructure for manufacturing and enterprise facilities approval. Review and Approve IS Management process for computer systems Infrastructure, Hardware and Software components in a qualified state and in compliance with current regulations and information systems standards and corporate GMP Manual and IS policies. Provide 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. Active participant of Enterprise Computer Systems such as Trackwise, GXPharma, ISOtrain, MES, LACES / Empower, etc.
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Qa ConsultantPharmaceutical Company Sep 2006 - Oct 2006Review of Commissioning and Qualification Protocols (Packaging lines, Facilities, Utilities) Development of Commissioning Plan, Commissioning Protocol, Functional Requirements, Software Requirements, Validation Plan, Qualification Protocol for a Clean Steam Generator. Manage resources allocation, metrics and timelines.
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Senior Validation ConsultantGenentech May 2006 - Aug 2006Develop and execute Qualification protocols for WRO, WFI, Tanks, and CIP. Develop Validation Plans for Utilities and Manufacturing Equipment. Develop and execute Qualification protocols for Water Reverse Osmosis, Water for Injection, Tanks, CIP, and Clean Steam. Develop. Supervise Validation Specialists and provide support to their activities. Meet with client to discuss schedule and events of the project. Develop and maintain project plans, metrics and resources. Facilitate and serve as a point of contact between the client and the Validation Specialists.
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Validation ConsultantGlaxosmithkline Pharma Gmbh Jan 2006 - Apr 2006Site under Concent Decree- Develop Validation Plan, Change Control Plan, Document Management Plan and Computer Qualification Protocols for the migration of BPCS software in a new iSeries (AS/400).
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Project ManagerCordis May 2005 - Dec 2005Project Manager of $4 million dollars and $1.5 million dollars projects for the construction and validation of four new coating suites and modification of a coating room respectively. Develop the validation schedule; coordinate all activities related to validation. Recruiting validation personnel. Decision maker of validation activities. Develop and maintain the status of the project using Microsoft Project. Supervise 55 resources. Manage CSV and manufacturing Equipment validation activities. Review/Approval of Deviations Report and Commissioning Protocols. Manage timelines, resources, metrics, and budget.
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Senior Validation ConsultantBristol-Myers Squibb Sep 2004 - May 2005FDA pre-approval inspection & upgrade audit program implemented to identify & correct potential FDA compliance gaps of a biotech plant. Validation of Biotechnological manufacturing equipments based on PAT. (Vessels, Tanks, Agitators, Autoclaves, Refrigerators, Filtration Units, Heat Exchanger, Bioreactors, WFI, SIP, CIP, IQ/OQ/PQ and CSV, System Life Cycle, User Requirements, Design Specifications, Requirement Traceability Matrix, Design and Functional Specifications of Chromatography Controllers, among others equipments). Development of System Boundary’s using P&ID’s. The temperature mapping was performed using the Kay Validatior. Coordinate validation activities against Validation Specialists. Serve as a point of contact between the client and Validation Specialists. Maintain timelines and metrics
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Senior Validation ConsultantRcm Technologies Aug 2004 - Sep 2004Pennsauken, New Jersey, UsDevelop a Bottle Standardization project and its validation, Review of Batch Records according to CFR 21 Part 11, 210, 211. -
Commissioning LeadMerck May 2004 - Aug 2004Rahway, New Jersey, UsDevelop Turnover Packages and Commissioning for a new facility -
Senior Validation ConsultantCardinal Health Mar 2004 - May 2004Develop and execute IQ, OQ, and PQ Validation Protocols for Freezers, Refrigerators using a Kaye Validator, Vial Filler Machines for Lyophilization Process, Water Bath, Balance. Perform Cleaning Validation of Lyophilization machines. Manage of resources allocation, metrics, Validation Plan. Coordinate Validation activities and facilitate and coordinate the project activities.
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Validation ConsultantMcneil Consumer & Specialty Pharmaceuticals Jan 2004 - Mar 2004UsDevelop and Execute IQ, OQ and PQ for Air Handling Units. -
Senior Validation ConsultantPharmacia Corporation Jul 2003 - Jan 2004Develop and execute of protocols for Cleaning Validations, Walk-in Coolers, AHU, Coater Machines, Compressing Machines, Capsule Filler Machines, Metal Detectors, Computer System Validations, Sorting Machines, Oscillators, Cappers, Validate Facilities and Utilities (Manufacturing Rooms, Compressed Air, Fire Alarm, Lighting, Vacuum, Dust Collector, Potable Water, Distilled Water), Develop Standard Operational Procedures, Batch Record Review, Process Validation. Manage resources allocation, timelines, develop and maintain project plans, budget and keep track and maintain metrics.
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Process SpecialistPharmacia (Searle & Co) Jan 2001 - Jan 2002Developed and executed manufacturing and packaging equipment, facilities, utilities, CSV, IQ/OQ/PQ protocols, process validation protocols and reports related to the manufacturing area (tablets/capsules). Participated in the validations of transfered products.Prepared and revised manufacturing standard operating procedures related to executed protocols and reports. Provided training and instructions to staff on implementing the new procedures.Developed Events Investigations Reports when deviations of the manufacturing and packaging process occurred. Participated in the MRB.Identified areas of opportunities in manufacturing operations to improve process efficiency and cost improvement. Analyzed current manufacturing and packaging process to update manufacturing and packaging Preventive Maintenance (PM) reports to assist in implementing the best business practices.Created and submitted Regulatory Documentation (labeling documents) to regulatory agencies.
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Compliance AnalystSearle & Co Jan 2000 - Jan 2001Audited manufacturing and packaging batch records and related documentation for lot disposition.Participated in the decision making related to compliance in manufacturing and packaging processes.Supported and actively participated in procedures (SOP's) revisions.Assisted manufacturing/packaging Improvers and Assurers in investigations due to in-process deviations.Approved investigations reports.Assist the Business Unit Management with the implementation and maintenance of Strategic Compliance Initiatives.Trained operators to correct non-conformance trends.Collected and reported trend analysis of errors found in manufacturing and packaging documentation.Provided documented feedback on non-conformance found in manufacturing and packaging documentation.
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Laboratory TechnicianSearle Ltd Jan 1998 - Jan 2000Supervised, organized and scheduled laboratory duties.Finished product and raw material reviewer and approver.Audit laboratory data, logging and validate finished products and methods.Analyzed finished, raw material, validations and stability product and using USP, EP/BP, JP and Searle procedures.
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Raw Material Lab ChemistryMcneil Consumer Products, Inc Jan 1997 - Mar 1998Analyzed raw material using USP, and McNeil procedures.Analyze in-process and finished product samples
Melvin Colón, Mem, Msmc Skills
Validation
Gmp
Fda
Capa
Change Control
21 Cfr Part 11
Quality Assurance
Quality System
Sop
Cleaning Validation
Quality Control
V&v
Biotechnology
Pharmaceutical Industry
Lims
Medical Devices
Gxp
Software Documentation
Computer System Validation
Gamp
Regulatory Requirements
Compliance
Regulatory Affairs
Technology Transfer
Aseptic Processing
Iso 13485
Manufacturing
Chromatography
Glp
Quality Auditing
Quality Management
Biopharmaceuticals
Project Management
Calibration
Trackwise
Chemistry
Spanish
Microbiology
Regulatory Submissions
Hplc
Document Management
Iso
Analytical Chemistry
Gcp
Validations
Pharmaceutical Consulting
Lifesciences
Project Planning
Root Cause Analysis
Melvin Colón, Mem, Msmc Education Details
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Universidad Politécnica De Puerto RicoManufacturing Competitiveness -
Universidad Politecnica De Puerto RicoEngineering Management
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University Of Puerto RicoIndustrial Chemistry
Frequently Asked Questions about Melvin Colón, Mem, Msmc
What company does Melvin Colón, Mem, Msmc work for?
Melvin Colón, Mem, Msmc works for Alvotech
What is Melvin Colón, Mem, Msmc's role at the current company?
Melvin Colón, Mem, Msmc's current role is Sr. QA Consultant.
What is Melvin Colón, Mem, Msmc's email address?
Melvin Colón, Mem, Msmc's email address is me****@****rtc.net
What schools did Melvin Colón, Mem, Msmc attend?
Melvin Colón, Mem, Msmc attended Universidad Politécnica De Puerto Rico, Universidad Politecnica De Puerto Rico, University Of Puerto Rico.
What are some of Melvin Colón, Mem, Msmc's interests?
Melvin Colón, Mem, Msmc has interest in Animal Welfare.
What skills is Melvin Colón, Mem, Msmc known for?
Melvin Colón, Mem, Msmc has skills like Validation, Gmp, Fda, Capa, Change Control, 21 Cfr Part 11, Quality Assurance, Quality System, Sop, Cleaning Validation, Quality Control, V&v.
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