Vince Rubino, Asq - Cqa Email & Phone Number

Blue Bell, Pa, Us

IPS has an office in Emeryville CA.IPS is a global leader in developing innovative business solutions for the biopharmaceutical and life sciences industries. Headquartered in Blue Bell, PA-USA, IPS is a multi-national company with over 1,400 professionals, and offices in the US, Canada, Brazil, UK, Ireland, Germany, Switzerland, Singapore, China, and India. IPS is one of the fastest growing global companies servicing the life sciences industry. Through their global reach and industry-leading knowledge, skill and passion, IPS provides consulting, engineering, architecture, construction, regulatory, and operational expertise that allow its clients to create and manufacture life-enhancing products around the world.Visit our website at www.ipsdb.com.

San Francisco, California, Us

• Develop process flow map to identify user requirements for proposed cell based agriculture manufacturing to include all units of operation, utilities, material and holding requirements.• Support search and evaluation of proposed GMP facility sites.• Evaluate novel food contact materials per §§ 174-178, 182-186 and JECFA database; reviewGenerally Recognized as Safe (GRAS) notices.• Identify cell bank screening requirements per Title 9 § 113.• Investigate 3-A Sanitary Standards, Inc. and EU Hygienic Engineering & Design Group (EHEDG)requirements for applicability to novel cell-ag bioreactor design.• Evaluate Singapore Food Authority (SFA) requirements for novel foods and Joint RegulatoryFramework for USDA-FSIS/FDA to guide development of Quality Policy.• Provide input for proposed IT, data acquisition and eQMS.• Participate in laboratory root cause investigation• Provide staffing plan for quality support of GMP pilot plant.

Hatboro, Pennsylvania, Us

Providing project management, process engineering, and quality compliance services including validation, supplier audit, CAPA investigation and SOP technical writing. Clients include: • Advanced Therapeutic Medicinal Product (ATMP) cell-based therapeutic start-up meeting FDA §§ 11, 210, 211, 610, 611 and 1271 requirements • in-vitro diagnostics (IVD) device developer and manufacturer meeting ISO 13485 and FDA §820 requirements

Richmond, California, Us

Establish quality system for GMP manufacture of novel biotherapeutics and cell-based agricultural products. Multiple simultaneous responsibilities in dynamic, start-up contract development and manufacturing organization.Registered first GMP facility with FDA for production and storage of engineered, clean meat.Established Quality Manual, Validation Master Plans, SOPs for Change Control, Deviation/CAPA Management, Good Documentation Practices, Calibration Program, Risk Management, Internal Audits, Training, Validation Program, Supplier Qualification and Document Control.Established SOPs for Food Allergen Management, Food Trace (forward and backward), Control and Disposal of Non-Conforming Food Ingredients and Food Defense.QA approval of calibration, recommissioning and qualification activities including clean utilities, QC equipment/instruments, upstream, downstream and drug product manufacturing systems for a pilot plant with two manufacturing suites.Practical, hands on experience simultaneously managing the differing quality and regulatory expectations for biopharma (§211 & §212 ) and food ingredient manufacturing (§117) validation and verification.

Richmond, California, Us

Leading the Commissioning and Qualification (C&Q) of biopharmaceutical and clean/engineered meat pilot plants for use as a Contract Development and Manufacturing Organization (CDMO).Second employee hired into quality organization reporting to QA/QC Vice President.In first 6 months on the job working across multiple disciplines and prioritizing company needs:Human Resource (HR) recruitment for start-up• QC Manager• Senior QA Scientist• Validation Staff including CSV lead• Calibration ManagerEstablish Quality Management System (QMS)• Author Validation Master Plan (VMP), GMP impact assessment, and Validation and Qualification Requirements SOP• Led establishment of engineering change management• Author Calibration Program SOP• Prolific company trainer with topics including EHS, validation program, change management, user requirements specifications, boiler operation and calibration program.• Author and manage engineering change requests for clean utilities • Investigate incidentsManage Validation Department• Project management for Recommissioning and Qualification effort for: o Facilities and utilities o Single use biopharmaceutical suite (Part 210 and 211) o Clean / engineered meat suite (Part 117)• Manage establishment of computerized data administration• Approve validation exception SOP• Author Building Automation System (BAS) protocol• Author 21 CFR Part 11 protocol• Approve URSs and protocols for clean utilities and controlled temperature environments• Lead classified clean room redesign to meet organizational goals and process needsLed establishment of the Environmental Health and Safety (EHS) Training Program and Committee for facility and laboratories• Author boiler operation SOP• Create safety incident reporting and investigation forms• Establish new employee and contractor safety training curricula

International supplier quality auditing - for cause and routine surveillance

Yeonsu-Gu, Incheon, Kr

Establish plan for training Return On Investment (ROI).Create and track training effectiveness metrics based on Kirkpatrick model using quality metrics to define impact to business goals.Conduct Voice of the Customer (VoC) surveys and reports to guide development of training approach and curricula.Generate the following training elements:- Trainee self assessments and training satisfaction survey- Create knowledge assessments for quality and compliance topics- Establish interactive, case studies and scenario based training material for investigators, SOP authors and staff performing deviations and change controls.- Create training planning and effectiveness survey for supervisors to measure training impact. - Create innovative Korean language Data Integrity training materials.

Yeonsu-Gu, Incheon, Kr

Lead commissioning, qualification and verification activities for Quality Control and upstream and downstream Drug Product manufacturing systems supporting new biopharmaceutical manufacturing plants.- Author validation plans, SOPs and forms by incorporating key stakeholder input- Establish protocol and report templates- Provide compliance training for validation plan and SOPs- Review and approve design documents, risk assessments, protocols and reports - Investigate and resolve deviations, exceptions and manage changes

San Rafael, Ca, Us

Lead team performing cleaning and steaming validation activities for multiple biopharmaceutical products in multiple facilities; initial validation and revalidation; upstream and downstream processes.

San Ramon, California, Us

March 2013 - presentContract engineer performing installation and operational qualification, and cleaning validation of equipment supporting biopharmaceutical processes. Perform system reviews of qualified equipment. Investigate cleaning validation discrepancies. Manage multiple simultaneous projects. Maintain project timelines and budgets. Work place located in SF Bay Area.Sept 2012- February 2013Contract engineer leading the commissioning, qualification and validation of controlled temperature and HEPA filtered equipment supporting biopharmaceutical processes in a workplace operating under consent decree and third party review.Work place located in greater Boston area.

서울, Kr

Audit, perform gap analysis and establish policy, procedures and training to support Quality Management System for Korean in vitro molecular diagnostic medical device developer and manufacturer meeting standards of ISO 13485 and US FDA 21 CFR Part 820.

Kr

Registered Quality Assurance Professional (RQAP) performing comprehensive independent Good Laboratory Practices (GLP) facility and SOP audits to include verification of validation and service of GLP systems. Provide executive consultation regarding US FDA and OECD GLP regulations and AAALAC requirements. Support QA Manager with auditor and regulator visits. Provide consultation and create draft SOPs for validation, CAPA and SOP lifecycle. Train staff to create process flow and Gantt charts to describe and track study and validation processes. Manage overseas marketing and business development department for pre-clinical Contract Research Organization (CRO) including three direct reports. Languages supported include Korean, English, Japanese and Chinese. Results: * US$ 2.1 million increase in annual sales from 2009 to 2010 * Sales for first half of 2011 more than 60% of total for 2010* 70% reduction in annual department expenses from 2008 to 2010 * Our institute received AAALAC re-accreditation in 2010 for quality animal care

Delegate supporting various disciplines within the ISO Technical Committee 229: Nanotechnologies.Duties include data mining and drafting and editing ISO standards and technical reports relating to nanoparticle toxicity studies and characterization methods relating to CNTs and other engineered nanomaterials.• Two nano inhalation test standards approved as international standards in 2010.• One technical report for preparation of safety data sheets for nano approved in 2012.

Upgrade quality systems for CRO following OECD GLP principles, Korean regional requirements and ISO 10993. Create and monitor quality objectives and generate reports to management. Perform facility and documentation audits for medical device and GLP teams. Create process flow charts and Gantt charts to track and assess quality improvement and GLP studies. Create or revise SOPs in collaboration with numerous technical experts and departments.

Leverkusen, North Rhine-Westphalia, De

QA support for development projects including design, construction and qualification of a Clinical Manufacturing Facility (CMF), design to commissioning for a pilot scale filling and freeze drying facility, and creation of a quality systems directive for R&D. Serve as QA representative on cross-functional project teams. Specific duties include reviewing user requirement specifications (URS), engineering specifications, qualification protocols, SOPs, FFDs, GMP change requests and material clearance requests. Ensure inclusion of stakeholders such as QC, HES and maintenance in projects. Provide documented training on QA topics as needed, to include change management. Perform batch record review for development project. Perform discrepancy dispositions. • Received Bayer Special Recognition Award for leading the expedited development of the test requirements and acceptance criteria for fast track commissioning and qualification for the CMF project.

Leverkusen, North Rhine-Westphalia, De

Facilities engineering, validation and other project management and engineering functions for cGMP production, QC and R&D internal customers. Tasks included facility improvements, change control requests, discrepancy initiation, investigation and corrective actions, performing validation of new equipment and ensuring maintenance of facilities, equipment and instrumentation.

Leverkusen, North Rhine-Westphalia, De

Generated and executed validation protocols for internal cGMP manufacturing customers. Evaluation of maintenance of validation integrity for requalified systems, SOP and DER generation also performed.

Bachelor Of Science - Bs, Bioengineering And Biomedical Engineering

Bioprocess Engineering

Biomedical Quality Systems

B.S., Bioengineering