| Candidate Information | | Title | Quality Assurance Project Manager | | Target Location | US-MA-Plymouth |
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Click here or scroll down to respond to this candidateSummary of QualificationsProject Manager with considerable experience in regulated Pharma and Medical Devices Industries. Good Manufacturing Practice (GMP)Strong knowledge of ISO 9001, ISO 13485, AS9100D, and compliance and cGMP.Strong knowledge of 21CFR 820, 21 CFR 211.Strong knowledge of Quality Management System (QMS), with focus on Management of Change Review, Change Control, Audits, and Risk Management.Followed ISO 11135 -1 Ethylene Oxide Method. Knowledge of ISO 17665-1 Moist Heat/ Sterilization method.Led and participated in multi-functional department team to work for CQV efforts that support business needs and meet global regulatory requirements.Senior Quality Assurance Engineer for internal and external audits acting as a SME.OQ, IQ and PQ of new equipment for Global Projects. Interfaced the equipment helping IT engineers.Six Sigma Greenbelt trained with significant project improvement.Value Engineering with emphasis on principles of performance evaluation and prediction to improve product/systems safety, reliability, and maintainability.Professional ExperienceNeedleTech Theragenics CorporationSenior Quality Assurance Engineer and R&DNorth Attleboro, MA 02760 July 2023 to March 2024Led validation of ETO Sterilization process. Worked with the Sterilization Lab and certified the cycle approved to run products at their facility.Validation of Bioburden Test Methods required by MDR submissions for customers Products, in collaboration with Ethide Lab.Performed design review and control prediction estimation on new product design. Applied failure mode effects and analysis.Planned reliability testing performed at a third-party lab. Including analysis of reliability testing and field failures and analysis. Evaluated performance improvement and reliability program including human factors.Supported cleaning operation according to ISO and ASTM Standards. Validated cleaning procedures per customer request.Supported Quality Management System group to incorporate improvement options to manage customer complaints and CAPAs.Led/supported supplier audits.Functioned as a liaison for new customers product requirements to meet FDA and EU ISO standards.Collaborated with Quality System team to resolve CAPAs, customer complaints, quality investigations, and risk assessment studies.Worked directly with external lab for the completion of Bioburden testing.Collaborated with manufacturing - managers on clean room guidance and revision of new clean room procedures.Denison PharmaceuticalValidation Team LeaderLincoln, RI December 2022 to April 2023Led and supported Technical Service Team on validation activities within Denison Pharmaceutical. This includes Engineering Batch protocols, Validation Work Orders, Manufacturing Batch records, Quality Summary reports to meet customer requirements.Led supplier quality audit for Active Pharmaceutical Ingredients and Biologics categories across Pharma segment.Reviewed documents on batch release and validation product runs, authored reports to client, performed data analysis associated with product validation/verification.Worked directly with procurement (project leaders) on approved suppliers of new raw material, new packaging design material and implementation of changes.Supported Validation of new Mixing Tanks with heat exchangers. Run DOEs to set variables according to product needs. Run validation cleaning procedures for the specific missing tank and feeding lines according to process flow. Validated temperature settings of the tank per product specifications.Supported change over product. Audited equipment cleaning process, via CIP. Examples: mixing tanks, piping system, filters, housings, homogenizers, and heat exchangers.Collaborated with procurement - product managers on revision of packaging components, new raw material for new product introduction, executed batch records, validation records, and summary reports, to submit to customers.Thermo Fisher ScientificSenior Process and Packaging EngineerMillersburg, PA February 2021 to December 2022Process engineer leader for the IQ, OQ, and PQ of a new checkweigher at packaging department in Millersburg, PA. A Computer interface validation was included. Collaborated with supplier on commissioning, qualification, and validation of two checkweighers.Process engineer leader for qualification of new film. Run DOE on makers to set up process variables. Authored Protocols for the DOE runs and final reports.Led and supported Quality for Packaging, coordinating Thermo Fisher segments. Partnered with Procurement on strategy, supporting budget on packaging components for all suppliers. Used methodologies for risk reduction, reliability improvements and initiative-taking quality improvements.Worked with Procurement on second source approved supplier list.Collaborated with cross functional team on Project led by customers. Delivered a product to Merck, West Point, PA.Led and supported packaging initiatives in conjunction with the customer team, delivering improvement on packaging components.Supported Quality Management System on Master Control planned and unplanned deviations. Worked with Quality Manager on disposition of material after deviation is approved.Supported Packaging Engineer team on validation and Qualification Materials for Single Use Products at Thermo Fisher Scientific Millersburg site.Reviewed and authored work instructions documents for operators to use on the packaging line.Worked with packaging team on issued CAPAs and managed to complete effectiveness of the CAPA.Worked with third party labs on the execution of ISTA transportation test for packaging components on final packed products.Authored protocol for the design, execution, and control of accelerated life test (HALT), in collaboration with a third-party laboratory. Identifying and evaluating where product defects and failures are likely to occur throughout the design development process and manufacturing stages.Worked with Logan site to perform HALT and HASS on new product development and introduction.WuXi AppTecSenior ConsultantPhiladelphia, PA January 2020 to July 2020Worked with Procurement on acquisition of over100 pieces of Lab equipment for testing services. End to end comprehensive testing platform of drug R&D and Medical devices.Collaborated with procurement on commissioning the R400 Lab pieces, qualified the lab equipment per design and validated them as part of the installation plan.Leader approver for Management of Change Control on WuXi App Tec Philadelphia site.Worked on issuance of Validation Protocols and approvals of new equipment for a new R400 project.Approver of new acquisition of two new vessel(s) reactor, run installation per protocol, and run implementation of its own computer control equipment. Performed Risk Assessment review and approval.Served as a Subject Matter expert on validation of new equipment.Merck & CoProject LeaderWest Point, PA March 2018 to September 2018Supported Packaging and Combination Product Commercialization Sterile team.Authored Packaging Components Specification for primary, secondary, tertiary and distribution components.Worked on issuance of Validation Protocols to reflect completeness and confirmed applicable corporate/site policies, procedures, and guidelines.Collaborated with a global team MMD and MSD sites on the issuance of Packaging Specifications applicable to specific Manufacturing sites.Provided Technical review for Global Suppliers Technical Specifications.Worked with MMD technical personnel on the testing protocol validation for the distribution of a Drug substance.Managed the Product Protocol Distribution Testing. Ensuring packaging materialsused in the testing are the same as actual product packaging and the solution meets general business needs. The test used simulated real distribution temperature conditions and dynamic transportation hazards.Managed a Distribution test run per Protocol at External Contract Lab.Performed high accelerated life test (HALT) components per design, at external Lab.Authored MMD and MSD final design packaging report for the distribution of a Drug substance.Served as a resource for other active projects.Ethicon, Inc. Part of Johnson & Johnson Family of CompaniesSupplier Quality EngineerSomerville, NJ July 2017 - January 2018Change Control leader for Ethicon India Global facilities. Major or Minor changes as prescribed per QMS SOP specifications.Supplier Quality Engineer, worked with External Manufactures.Provided review of Technical Assessments and audits performed at Supplier site for compliance with regulations. Assisted in addressing minor and major audit observations. Maintained records per Ethicon Quality Management System (QMS) requirements.Participated in weekly meetings with Ethicon cross functional team and Supplier team reviewing MRV and mitigation plans associated with observations.Team member of the Drain products team, participated in PFT weekly meetings.Reviewer of Root Cause Investigation and Risk pFMEA associated with Non-Conformances complaints.Managed and supported India on FDA Major findings. Addressed FDA request and resume production at India.Dow Chemical Manufacturing Excipient GMP Project LeaderCroydon, PA May to December 2016Excipient Good Manufacturing Practice (GMP) Project Coordinator at DCM. Authored Excipient and Cosmetic Good Manufacturing Practices Policy at Croydon manufacturing site.Led and authored GMP policy revisions at Croydon Manufacturing site.Reviewer of Root Cause Investigation policy and Risk FMEA policy associated with the production of Excipient products.Audited Third Party Manufacturing Plants, as part of the Qualification of third-party supplier -packaging plant. Performed an Audit with Dow Corporate Quality Engineer comply with Dow GMP specifications and ISO standards.Led validation of transporting dedicated trucks, which allowed the company to transport the excipient product to a third-party facility for the drying process. This included cleaning the tank via CIP, an approved method designed to remove residual products and biofilms using turbulent cleaning fluid and steam, without removing connecting tubing.Updated the DOW Quality Management System at Croydon-plant level.Johnson & Johnson Consumer Companies INC. October 2013 July 2015Quality and Supplier Excellence Project LeaderSkillman, NJWorked with Quality Management System group updating Global Policies and procedures.Managed QMS -Change Control. Approver for project that triggers a Change Control approval. Product Life Cycle approvals.Led Supplier Feed Back Specification Project, to improve communication with Suppliers. A new application program was successfully launched to work with Raw Material and Packaging Suppliers because of a CAPA Project.Led Packaging Supplier CAPA 04061 Project to completion.Worked with Packaging Suppliers on a Supplier Change Notification Agreement and COC Inclusion Agreement with Johnson & Johnson Consumer Products in NA.Managed Packaging Supplier Database. Updated database of CAPA 04061 project development.Worked with QMS as SQA approver for Raw Materials Specifications, reviewer of GCC as applicable for the modified Specifications. Assisted GCC for minor or major changes to Raw Material Specifications. Assisted on qualification or requalification of Suppliers.Worked with Audit Plan 2016-2017 Global QMS target. As a team member, I reviewed Audit frequency and audit status for Raw Material and Packaging Suppliers and addressed the needs per Consumer Product goals for the next 5-years.Project Leader for Computer Validation on the Supplier Feedback System (SFS) Project. Authored the SOP for the implementation of new IT tool and authored the compliance wire training document prior to implementation.Led Supplier Quality for packaging components for all products at consumer products.Completed enterprise quality agreements, closing compliance gaps, by covering spend of more than $50M.Worked with Procurement on agreements negotiation, in conjunction with Quality VP and Legal department to collaboratively negotiate the agreement with potential suppliers.Led use of data and analysis tools to identify trends with suppliers across business by developing a global strategy good supplier practice.Innovize October 2011 September 2012Quality Engineer, 2012St. Paul, MNLed Supplier Chain program. Managed QMS - Supplier Database using Master Control. Managed Suppliers Score Card database.Supported qualification of new products on a clean room environment. Authored in process testing procedures, and performance testing of the final product. Analyzed performance data of the product using Minitab. Compared cPk and pPk per customer specifications.Collaborated with customers on a qualification of new products using clean room equipment, wrote process specifications: set up & clean up procedures per customers specification.Managed quality test procedures for existing and/or new products at different makers at Innovize.Authored customer product specifications using SAP Quality Module.Managed IQ/OQ and PQ validation of new testing equipment, existing press equipment and modification to existing makers. Analyzed quality data for difference phases of the qualification.Authored incoming inspection procedures, standards (product specification per product standards using Master Control. Trained operator on usage of new procedure. Initiated Scars to suppliers when packaging material did not pass the incoming inspection. Trend and follow up scars issuance in the system.Approved and released of product following product standards, product specifications and GMP.Using Master Control in compliance with the Quality Management System, initiate quality improvement projects providing support to corporate initiatives to manufacture and to minimize cost without affecting quality.Executed Gage R&R studies and analyzed using Minitab to support PQ validation for new packaging line and material.Mentored quality personnel on internal site Audits preparation and execution.Collaborated with suppliers on the approval of new plates, new drawings for the screen-printing operations and press operations meeting customer product specifications.Mentored and Led plan efforts to incorporate Process Safety Management.Diasorin March 2010 - October2011Quality Engineer, 2011Stillwater, MNQuality Engineer for diagnostic kits used on LIASON systems manufactured by Diasorin, ELISA and RIA technology. Driving continuous quality improvement projects to meet and exceed customer satisfaction.Member of CMC project optimization. Worked with R&D, Lab trial, and production. Set Controls with ownership of general supervisors.Managed CAPA system effectiveness and reported to upper management monthly.Led plant efforts for the implementation of Root Cause Analysis Methodology. Leader of Nonconformance Investigation. Developed and trained personnel on the use of cause-and-effect Fishbone, 5 Whys, FMEA. Initiate investigation of nonconformance on a case-by-case basis. Implemented corrective actions and/or preventive actions because of the investigation.Assessment for the modifications of equipment or new installation. Analyzed data for phase reviews, presented the data to Managers for introduction of new product/process.Performed the review and approval of Design Input variables following QSR for Design Controls requirements.Team member of Bar Code implementation as part of SAP inventory process.Quality Engineer for the Customer Complaints Reduction project analyzes data. Incorporated Voice of the Customer on issues related to Quality of our product.3M Company 2003-2009Advanced Process Engineer, 2007 to 2009Menomonie, WI - Personal Care Division - ManufacturingProcess Engineer for a Micro replicated extrusion line.Led a Six Sigma Yield Project on Hook line 2: increasing yield from 84% to 91%.Experience analyzing quality data using Minitab , control charts and capability analysis. Implemented a control/reaction plan for the product/process reflecting changes during a yield and quality improvement project.Assist in 3M Global Environmental Management System towards Global Safety & Health Plan program maintenance and performance improvement.Advanced Process Engineer, 2003 to 2006Nevada, MO - Commercial Graphics, IATD, Medical Divisions - ManufacturingProcess Engineer assigned to extruders, Comply and Microcomply Liner equipment, and coating equipment.Led plant efforts to qualify Medical extruded film to off-load Brookingss facility.Led and participated in cross functional Six Sigma teams and New Product Development teams saving > $ 300,000/yr.Led process/product improvements through development, experimentation, and scale-up phases.Authored and analyzed MSA studies for different quality test methods using Minitab.Participated in lean manufacturing initiatives.Provided EHS support in the coordination of safety training, incident reviews, preventive policies.SEBESTA BLOMBERG, Roseville, MN 2000-2001Environmental Project ManagerConsulted clients on environmental impact of new manufacturing processes. Provided services and completed Air Quality applications for federal and state air permits.Collaborated with a team to implement Hazardous Waste Management for projects that triggered a revision. Developed an action plan for the prevention of contamination of underground water applicable to a specific site.MINNESOTA POLLUTION CONTROL AGENCY, St. Paul, MN 1997-2000Air Quality Permit EngineerAuthored permits for major sources of air pollution, Title V Air permits for 3M Cottage Grove, 3M Stillwater as well as major permits for major facilities in Hutchinson, St. Paul, and Alexandria, MN. Project leader for Title V permits for major sources in Twin Cities.MASSACHUSETTS DEPARTMENT OF ENVIRONMENTAL PROTECTIONSpringfield, MA 1994-1995Air Quality Permit EngineerAuthored Air Quality Permits for Minor and Major sources in Western Part of MA.Reviewed Title V Air Quality permit applications for major sources.Worked with Multimedia team on accessing measurement of success of DEP Initiative.Worked with Air Quality group on emissions reports from sources.EducationMaster Business Administration, University of Wisconsin, River Falls, WI (Enrolled Spring 2006).Master of Science, Chemical Engineering, University of Nebraska, Lincoln, NE.Bachelor of Science, Chemical Engineering, St. Agustin National University, Arequipa, Peru. |
