Manuel Cabasa

Marblehead, MA ***** adsrvq@r.postjobfree.com 603-***-**** /781-***-****

WORK HISTORY

From 2018 to present

Company: Millipore Sigma Merck group

Title: Cell coordinator Final fill level 4

Duties: responsible of all special jobs, qualities, perfections, LEADWAY AFRICA 1990- 2003 Quality control insurance and customer care skills

administrations, management, customer Service, Customer satisfaction, management team leader, Supply chain, procurement, Emergency management, Investigation and audits, Analyst, contact centers, accounting management, operations management, Customer care Specialist Service management, Microsoft office word, Excel, PowerPoint, one note, outlook, organization, Analysis, inventory. Investigator the professions. I do have variety of practical skill the main Skill and my qualification area:

1- familiarity with Quality standards and process to follow federal, State and local regulations.

2- Communication skill to convey information in reports, meetings and status reports 3- knowledge of product to perform accurate quality control attention to detail. 4- Analysis, Critical-thinking and problem-solving skill to review system, find flaws and pose solutions to those flaws.

5- Interpersonal skill

6- Ability to handle stress

7- Ability to operate under deadlines with still meeting standards QUALITY ASSURANCE, SPECIALYZING IN ANALYSIS

Duties, accomplishment, and Related skill:

Performing work in the manufacturing industry. Performing quality Assurance and compliance manager supporting a team of 60 personal plus 4 supervisor’s and supporting manufacturing operations relative to the production (SOP) to the production of commercial and clinical product. Responsible for the providing quality of commercial and clinical product, Responsible of quality and technical support for commissioning, qualification activities related to manufacturing equipment, process, and utilities. I support and I facilitate the development and review of project plans, qualification protocols after the final product and reports for stages of the qualification process, maintaining quality standards aligned with I FDA, CGMP, ICH and applicable international regulations and Guidance documents, I provide compliance oversight and support to GMP operation, my Job is to ensure cleanroom aseptic behavior are followed throughout the manufacturing process and personnel are trained in the job they perform. QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories. Qualification various equipment, such as utility equipment, lyophilized, environmental monitoring system, labelers, liquid ampoule filler/power auger, serialization system, vacuum chamber.

Assessment of equipment/instruction related change control to assure proper impact assessment to develop and maintain a qualified/validated state and review or assist in investigating deviations related to manufacturing, process equipment, utilities automation, computer system, validation, qualification, requalification protocols and perform monthly compliance walkthroughs and help drive the closure of any observations. And, to Assist with internal and external Audits.

Speaking languages. Portuguese, English, Spanish, French, Kikongo, Africans, Zulu, Chokwe Implement and maintain tracking and trending to identify potential out of trend Maintain departmental budgets within established guidelines Define quality expectations and lead/support collaborations with both internal and external customers

Develop and execute plans for test method validation, component qualification criteria, raw material sampling plan, and adherence to the PDP system Provided management oversight and signature approval of product and process qualification plans and implementation results

Work with teams to determine root causes for non-conformances to QC testing plans and to customer contractual requirements

Coordinated and successfully lead multiple domestic and international customer assessment teams approving the new QMS system

Insure timely execution of all required testing

Assess contractual requirements, develop and maintain checklists, and communicate within site functions with regard

Transitioned existing paper document management system Promote a safety first culture

Manage Quality through leadership and product expertise (RCA, Audit, Complaints, QMS) Maintain and drive comprehensive quality metrics associated with span of control, including developing and driving appropriate performance KPIs, managing timelines and working with site stakeholders

Implement systems to increase the speed and quality of key processes and drive business and process improvements

Develop and report on Quality metrics for the QC lab Manage a team of Quality Engineers and is responsible for maintaining the Quality Overseeing Quality Control teams that perform environmental testing, raw material testing Work with team to initiate development plans for QC Scientists Implement robust quality systems through data analysis Manage and develop the team that supports the daily operations of the Quality Control group Create and implement inspection and testing criteria or procedures. Identify quality problems or areas for improvement and recommend solutions. Monitor performance of quality control systems to ensure effectiveness and efficiency. Review and update standard operating procedures or quality assurance departments, outside vendors, or contractors.

Participate in the development of product specifications. Instruct staff in quality control and analytical procedures. Confer with marketing and sales departments to define client requirements and expectations. Verify that raw materials, purchased parts or components, in-process samples, and finished products meet established testing and inspection standards. Identify critical points in the manufacturing process and specify sampling procedures to be used at these points. Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control. Instruct vendors or contractors on quality guidelines, testing procedures, or ways to eliminate deficiencies.

Review quality documentation necessary for regulatory submissions and inspections. Analyze quality control test results and provide feedback and interpretation to production management or staff.

Coordinate the selection and implementation of quality control equipment, such as inspection gauges.

Direct product testing activities throughout production cycles. Collect and analyze production samples to evaluate quality. Pk Management, LLC, Manager customer ca re Service 08/2004 - 02/2012 Responsible for scheduling, managing, monitoring and completing homebuyer orientations, maintenance reviews, and warranty repair requests in an average of 7 days or less, while ensuring building codes and company standards are being met, at the same time bolstering a positive image of the company.

[ key Achievement] Recognize as the Customer Care Manager with the Highest percentage of warranty concerns completed in the PK management, named top Customer Care Manager in the south of Africa with 92% of warranty request completed in 7 days or less Created a new hire orientation and onboarding program for all new employees Administer companywide 360 Degree Feedback program

Assist in recruiting for 3 corporate locations

Completely new hire training and follows up with field supervisors to determine continued training needs for staff Complete audits throughout the department and efficient use of database system

Ensure compliance with the screening and hiring decisions according to federal, state and local laws Assist with other Human Resource responsibilities Contract with vendors to provide employee services, such as food service, transportation, or relocation service.

Perform difficult staffing duties, including dealing with understaffing, refereeing disputes, firing employees, and administering disciplinary procedures. Analyze statistical data and reports to identify and determine causes of personnel problems and develop recommendations for improvement of organization's personnel policies and practices. Identify staff vacancies and recruit, interview and select applicants. Analyze and modify compensation and benefits policies to establish competitive programs and ensure compliance with legal requirements.

Plan, direct, supervise, and coordinate work activities of subordinates and staff relating to employment, compensation, labor relations, and employee relations. Investigate and report on industrial accidents for insurance carriers.

Advise managers on organizational policy matters, such as equal employment opportunity and sexual harassment, and recommend needed changes.

Plan and conduct new employee orientation to foster positive attitude toward organizational objectives.

Conduct exit interviews to identify reasons for employee termination. Serve as a link between management and employees by handling questions, interpreting and administering contracts and helping resolve work-related problems. Analyze training needs to design employee development, language training, and health and safety programs.

Study legislation, arbitration decisions, and collective bargaining contracts to assess industry trends.

Develop or administer special projects in areas such as pay equity, savings bond programs, day care, and employee awards.

Prepare personnel forecast to project employment needs. Administer compensation, benefits and performance management systems, and safety and recreation programs.

Maintain records and compile statistical reports concerning personnel-related data such as hires, transfers, performance appraisals, and absenteeism rates. Prepare and follow budgets for personnel operations.

Represent organization at personnel-related hearings and investigations. Oversee the evaluation, classification and rating of occupations and job positions. Allocate human resources, ensuring appropriate matches between personnel. Plan, organize, direct, control, or coordinate the personnel, training, or labor relations activities of an organization.

Negotiate bargaining agreements and help interpret labor contracts. Provide current and prospective employees with information about policies, job duties, working conditions, wages, opportunities for promotion, and employee benefits. Provide terminated employees with outplacement or relocation assistance. Sonangol Services Inc., Production Supervisor 03/2000 - 07/2004 Strategic oversight of safety, production, quality, and cost controls, Recognition as a company resource, significantly contribution in $275k annual savings, time wastage reduction, and workflow enhancements through numerous kaizen process improvements on products and services delivery. Successful expectation of product delivery by 59% bosting client’s satisfaction scores and company profit, conceptualization and recommendation of partial production line-end automation, which obtained 25%-time savings and seamless work ergonomics Obtainment of two Making a difference Awards by demonstrating exemplary work performance and professionalism. Direct operational or production activities. Exchange information with colleagues. Plan production or operational procedures or sequences. Inspect production equipment. Instruct workers to use equipment or perform technical procedures.

Monitor equipment operation to ensure proper functioning. Record operational or production data.

Order materials, supplies, or equipment.

Study blueprints or other instructions to determine equipment setup requirements. Confer with others to resolve production problems or equipment malfunctions. Trainer of all the leads and coordinator.

Masstran Danvers team Lead supplied Development team lead 18/2013 to 6/2017 Team Lead for the supplied Development function within the transmission strategic business unit, ensure team compliance to specified process, balance team member workload. Achievements, 50% improvement in quality control & Delivery Performance with one Masstran place to 10 ranked worst Delivery performing suppliers. Development and implementation selection tool, based on quality control delivery, cost performance and strategic souring classification. $200k of reduction in cost of non-quality through application of 7-Steps Problem Resolution process

EMD Millipore Sigma Danvers Ma 17 cherry Hill Dr

24-AUG-2018 Cell Coordinator in All the Special jobs. key Responsibilities Adherence to compliance requirements (safety, quality, and Environmental) Operating the process equipment in according with the batch record, user manuals, design parameters and current standard operating procedures. Receiving and verifying all raw materials, intermediates, consumables and/or solves Monitoring and collecting data on critical parameters to anticipate potential process upsets i.e., completion of batch records, using DCS, OSOP, working with Maintenance and technical Support.

EDUCATION

Liberty Homeland UNIVERSITY University Security. ON KINSHASA of Virginia 2017 CONGO to 2021 [Kinshasa Masters’ Republic Degree Democratic at Criminal of Justice Congo] System in Completion Date: October/ 15/ 1995

Degree/Level Attained: Bachelor’s

Major: Science in Letters, Minor Philosophy Credit :145.5 Relevant Anthropology; Africa; Law; Coursework, Statistics; Philosophy Licensures, History of Art; and Philosophy Science Certifications: Methodology; of Language; Philosophical History African Anthropology; of Africa Linguistics; Philosophy; Cultural History of Epistemology; Metaphysics; Modern and Contemporary Time; Sociology and General Anthropology; General Linguistics; History of Zaire (Congo); Techniques of Oral Written Expression; French; English; Portuguese; Spanish; General Philosophy, Mathematics; Education and Citizenship; Introduction to History of Philosophy; Introduction to Scientific Research; Moral Philosophy; Logic; History of Philosophy; Informatics. CONCLUSION

I have knowledge and ability to apply Quality principles and cGMPs in conformance to standards, and I prefer gained from working in a Manufacturing, QA and QC environment. I do have ability to demonstrated excellent communication: verbal, written, and presentation skill. I can also Demonstrated ability to interact effectively with peers, management, and cross functional teams., I have excellent attention, project and time management skill, and the ability to manage multiple priorities with aggressive timelines. I can be flexible in terms of working hours to meet requirements of position. Sound knowledge of pharmaceutical quality system requirements. I have knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

Skill to independently evaluate situations and propose potential solution are essential. Am a self- starter with a hands-on approach and a can-do attitude, an ability to think strategically and to proactively identify issue in various aspects of the drug manufacturing process. More than 15 years of experience in the pharmaceutical, biopharmaceutical or related industry and experienced in the FDA regulated pharmaceutical or medical device industries. Experience performing inspections and investigations, and Experience with EDMS, Trackwise, LMS preferred

Experience performing inspections and investigations, and Experience with EDMS.

Contact this candidate