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Dedicated Clinical Laboratory Scientist and Quality Control Expert with over ten years of experience in academic, research, and manufacturing laboratory environments. Proven track record in enhancing quality standards and fostering a culture of excellence in testing procedures. Skilled in leading laboratory operations and implementing effective quality control measures. Seeking to leverage my leadership experience in a challenging role focused on quality assurance and continuous improvement.

As a seasoned professional with experience [13 solid years] in Safety Data Sheet (SDS) authoring, I have honed a deep understanding of regulatory standards governing chemical product safety. My meticulous approach to crafting SDSs ensures the correct communication of product hazards, safe handling procedures, and compliance with intricate regulatory guidelines. This firsthand experience has equipped me with the ability to interpret and apply complex regulatory requirements, ensuring that products adhere to stringent compliance standards across various areas. Moreover, my role in SDS authoring has ingrained in me an acute diligence, where precision and accuracy are paramount. This skill set seamlessly aligns with your needs at CGI; responsibilities of Product safety and Regulatory compliance, where thorough evaluation of product compliance, documentation, and regulatory adherence is essential. As you know, it is extremely hard to talk about regulation and compliance without securing safety. Being well-versed in hazard communication elements and risk assessment through SDS authoring, I am adept at navigating multifaceted regulatory landscapes to uphold the overall product safety and regulatory compliance efforts. Therefore, I believe I am the right fit for your job opening. Versatile Content Writer proficient in researching, writing and editing diverse content. Works with minimal input to produce engaging, authoritative and error-free work. Autonomous yet communicative with [13]-year history of superior performance in remote environments.

Manufacturing professional with deep understanding of production workflows and machinery maintenance. Proven ability to enhance efficiency and drive continuous improvements in fast-paced environment. Adept at collaborating with team members to meet production goals and adapt to shifting priorities. Known for strong problem-solving skills and attention to detail. Highly motivated and detail-oriented professional with proven track record of troubleshooting, repairing and maintaining production machinery and equipment to achieve optimal efficiency. Proficient in understanding and interpreting blueprints, schematics and technical drawings to manage equipment according to specifications.


  ~Lean Six Sigma~Quality Systems & Compliance~Leadership~Team Building~Process Improvement Expertise

1.) Merck Pharmaceuticals, Jaffrey NH~Lean Six Sigma Black Belt-QC Associate
2.) DuPont Pharmaceuticals, Billerica MA~Microbiology Associate Scientist
3.) Bayer Pharmaceuticals, Fitchburg MA~Quality Control/Quality Assurance
4.) Lonza Biologic, Special Modalities (LSA), Portsmouth NN QA Systems Manager
~Completed 40 Lean Six Sigma Projects with total ROI exceeding $25 Million, including a Process Capability Study on Viresolve Pro, saving over a $1,000,000 on each batch.
~Trained in teaching complete DMAIC methodology including LEAN to include a full day and half day agenda.
~Played a key role in implementing the Total QMS at Merck in the Membrane Analytical Laboratory in 2022, working with five different shifts
~Trained and Experienced in External Manufacturing as well as API/Drug Substance (Active Pharmaceutical Ingredient) to include Cardiolite and Aspirin.
~Trained and Experienced in Small Molecule Production and Manufacturing as well as Contract Development and Manufacturing Organization (CDMO) with DuPont Pharmaceuticals
~Highly trained, with over 30 years of experience, in all aspects of cGMP, cGDP and cGLP
~Applied Quality Control Tools and Techniques, Six Sigma and Lean framework at Dupont and Merck
~Proven Time Tested Team building experience, promoting daily, a Culture of Quality and Continuous Improvement, motivating, mentoring and managing team members using process and performance metrics to drive change and continuously grow each and every day.
~Strong knowledge base in Project Management, both waterfall and agile, with an applicable understanding of corporate alignment and strategic planning.
~Deployed Project Charters at both Dupont Pharmaceuticals and Merck using standard deployment technique-Performance, Cost and Time, reducing variation, defects and money ($294,000 Projected for 2023)
~Skilled, refined and battle tested in creating a Culture of Quality, Value-Added, Voice of the Customer, Right the first time working environment with 29 years of experience.
~Skilled in Value Stream Mapping, Process Mapping and Standardizing Procedural and Process improvements with proven track record at Merck, DuPont and Bayer Pharmaceuticals
~Highly developed written and verbal communication skills, communicating with both internal and external customers as well as upper management
~Would interface with multiple functional areas and staff members on a daily basis, serving as the Voice of The Customer (VOC), Quality Control SME, Project Manager and the Continuous Improvement Specialist.
~Reported monthly and quarterly Quality Control metrics to Director of Corporate Quality Operations
~Initiated and verified Change Control documentation to include TrackWise for Deviations, investigations and CAPA
~Used Excel, MiniTab, Smartsheets, Power BI and Microsoft Projects to manage and oversee all Quality records and various performance metrics for accuracy and compliance at Merck in 2021 and 2022
~As the Continuous Improvement/Lean Six Sigma Black Belt regularly met with Customers to discuss possible changes, metrics of concern, projects or any deviations, CAPA, investigations or other relevant issues
~Cross Functionally facilitated all Quality Control Project Meetings as well as Process Improvement meetings in 2022 and 2023 as the Lean Six Sigma Black Belt.
~An empathetic and experienced agent of change, equipped to generate value and customer satisfaction in any process.
~A dedicated Leader with a foundational gift to listen and relate on a personal level.
~A Detail oriented self starter with strong organizational skills
~Ability to handle multiple issues cross functionally with a high degree of accuracy (problems, projects, personnel, equipment, etc.)
~Supported department leaders in Lean deployment and implementation, problem solving methodology and change management-very analytical and data driven
~Partner with Functional leadership to help orientation and training regarding policies, regulations, procedure, clinical record structure and documentation standards applicable for pre-clinical and clinical GXP activities.
~Direct and facilitate strong cross-functional communication by building working relationships across the organization.
~Directed growing Quality department programs by serving as the Key Subject Matter Expert and implementing fit for purpose standardized processes.
~Oversaw and drove a Culture of achievement and accountability with DuPont and Merck.
~Oversaw collaborations with finance, functional heads and team representatives to develop and manage program budgets and scenario planning at DuPont.
~Cross-functional support for all relevant Quality GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH, ISO).
~Oversaw development and maintenance of Quality documentation, coordinated document development, assuring proper reviews, approvals and training programs.
~Developed, tracked and routinely published Key Quality System metrics and data at both DuPont and Merck.
~Directed Continuous improvement of Quality Systems to assure quality and adherence with GMP and inspection readiness.
~Directed and supervised employees to ensure daily performance was appropriate to department and organizational goals and objectives.
~Created assignments for employees in an efficient and equitable manner to achieve quality performance and align with company and department goals and objectives.
~Provided instructions, explanations and performance evaluations
~Directed and advised employees of performance requirements and review work status progress for individual and group basis.

Senior legal professional and operations executive with 15+ years of combined experience across immigration law, law-firm management, hospitality operations, Non profit work and business development. Proven expertise in regulatory compliance, strategic leadership, client advisory, and financial oversight. Strong record of managing multidisciplinary teams, complex files, and regulated environments.

Dynamic Senior Sales Specialist with a proven track record at Sunrise Chevrolet, excelling in negotiation and relationship building. Achieved significant sales growth by streamlining processes and enhancing customer engagement.

Laboratory Technician with experience at Levins Drugs, skilled in compound formulation and laboratory testing. Proven ability to enhance workflow efficiency and maintain high accuracy in results. Adept at collaborating with teams and adapting quickly to new challenges, ensuring quality and safety in all procedures.

Experienced Physical Therapist Assistant with 3+ years of consistent employment, specializing in pediatric, orthopedic, and neurological rehabilitation. Strong background in delivering safe, effective treatment. Highly motivated to transition into home health services in the Queens area, bringing strong communication and documention skills and adaptability to diverse patient needs.

Monitored manual and automated equipment functions to align with production goals and quality standards. Assisted colleagues in improving wafer and optical component processing to enhance workflow efficiency. Utilized computer applications to evaluate operational processes and recommend adjustments to increase productivity. Supported analysis of procedures to identify quality concerns and promote ongoing improvement efforts.
Conducted inspections and maintenance to maintain a clean and safe work environment for personnel. Assisted with various assignments from supervisor, demonstrating adaptability and support for team goals.

Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.

Joshua Rodriguez

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Manufacturing Operator

Freight/Customer Service Associate

Education

High School Diploma -

Skills

Accomplishments

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Manufacturing Operator

Freight/Customer Service Associate

High School Diploma -

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