Joel Jose González Alcazar
Florida
Summary
Dynamic and adaptable professional with a proven track record at Pfizer/Viatris in improving team competency and process efficiency. With direct experience in Quality Assurance, Quality Control, Research, Validations, Disposition, among others. Thanks to these skills he has advanced knowledge in different regulatory guidelines such as GMP and GLP, OSHA, and also has experience in FDA regulatory requirements.
Process-oriented expert with proven ability to optimize operations and improve production efficiency in the manufacturing and quality control environment. Known for strong collaboration skills and results-oriented approach, adapting to changing needs seamlessly.
Overview
9
9
years of professional experience
Work History
QA In ProcessTechnician
Pfizer/Viatris
11.2023 - Current
- Disposition of Raw Material for DP and API.
- Verification and disposition of materials in Stockroom and packaging components.
- Disposition for rejected raw materials and packaging components in SAP system and physically.
- Process and report analytical data using computer systems (QDA, SAP, LIMS, etc.).
- Audit finished Drug Product electronic batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
- Management of balance and reconciliation of batches in manufacturing.
- Prescription verification, Startup and final report in modules, Close work orders, perform visual inspection to verify the feathered edge of the tablets. Giving dry reports and checking extensions in manufacturing.
- Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.
- Evaluate all deviations documented in batch records and determine the need for a corrective action.
- Verification, approval and registration of samples of packaging components.
- Labels verification like sample, rejected, hold, shipped under quarantine. Bulk Labels for DP and API approval.
- Sample evaluation and inspection sheet for packaging components.
- Verification of fiber, metal and plastic drones for use.
- Creation, update and modification of specifications (Change Management System).
- File, Management, and control of product reserve samples.
- Test samples such as average weight, thickness, and hardness in tablets.
- Enter required batch information into the lot restriction management system.
- Specimen sheet for PDO (Production Document Order)
- Perform testing for packaging components, intermediate products and finished products.
- Moving materials from restricted to unrestricted used for manufacture use only.
- Give timely disposition to materials in the SAP system based upon the result of testing and compliance with Regulatory Agency requirements.
- Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product also Certificate of Manufacture.
- Verify that Laboratory procedures and specifications are consistent with other site procedures and/or specifications and follow Guidelines.
- Use approved validated methods and specifications to perform required testing of finished products, API’s, biological drug substances, raw materials, intermediates / components.
- Maintain records of all work performed and document testing results as per Good Documentation Practices
- Perform inspections and processing audits.
- Audit the manufacturing processes to assure compliance with cGMP’S.
- Data entry of logbooks from Manufacturing.
- Maintains file sample system, logbooks, numbered star cards, controlling inventory level and disposal.
- Maintains necessary supplies and performs routine housekeeping duties.
- Provides samples and records as part of the investigation process or regulatory audits.
- Respond to questions from audits and be part of the investigation in process.
- Make forms and execute them for sample rejections.
- Trained new technicians in proper usage of equipment, safety protocols, and company procedures, ensuring a high level of competence across the team.
- Supported an environment of safety through thorough knowledge of regulations, best practices, and consistent communication with team members regarding safe work habits.
- Troubleshot technical issues, implementing solutions to maintain a smooth production process.
- Contributed to the development of standard operating procedures that improved consistency across shifts and reduced training time for new hires.
Security Officer
T. A. Security
04.2023 - 04.2024
- Greeted guests professionally and courteously to cultivate welcoming atmosphere while making safety top priority.
- Acted quickly during emergency situations to reduce opportunity for damage and injury.
- Patrolled and monitored premises in company vehicle and by foot.
- Provided excellent customer service while addressing visitor inquiries or concerns related to facility safety or access control procedures.
- Reported suspicious activities and persons to law enforcement.
- Trained new Security Officers in company policies, ensuring consistent knowledge across the team and adherence to established procedures.
- Reduced incident response times by implementing efficient emergency procedures and collaborating with local law enforcement agencies.
- Remained calm, assertive, and mindful to think critically and problem solve during stressful situations.
- Monitored CCTV cameras and alarm systems for security breaches.
Merchandiser Specialist
Suiza Dairy
01.2018 - 11.2023
- Maintained a clean and organized store environment to facilitate positive shopping experiences for customers.
- Proactively addressed potential issues or concerns related to merchandise presentation or inventory control before escalating them as problems.
- Utilized data-driven insights to inform decisions about product assortments that would resonate well with target customers.
- Optimized product placement by analyzing store layout, customer flow, and sales data.
- Implemented planogram changes according to corporate guidelines while maintaining visual appeal of the sales floor.
- Trained new merchandisers on company policies, procedures, tools, and best practices to ensure consistent performance across the team.
- Developed strong relationships with key clients to secure long-term partnerships and drive repeat business opportunities.
- Boosted brand visibility by creating eye-catching window displays that showcased seasonal trends and featured products effectively.
Laboratory Assistant
University of Puerto Rico
01.2021 - 05.2021
- Handled hazardous materials responsibly following proper waste disposal procedures to minimize environmental impact.
- Actively participated in lab safety inspections, identifying potential hazards and implementing corrective actions promptly.
- Maintained documentation on tests performed in lab.
- Tracked collected specimens by initialing, dating, and noting times of collection.
- Assist in the preparation of mixtures, reagents and culture media such as MacConkey agar, potato dextrose agar and EC broth.
- Sterilization of tools by using an autoclave.
- Classification of different types of samples.
- Identification of the necessary equipment such as pipettes, tubes and petri dishes to perform a procedure.
- Teaching new students how to use the laboratory facilities and materials such as the microscope, the burner, among others.
- Served as a reliable source of information for colleagues seeking assistance or clarification on laboratory procedures or equipment use.
- Maintained safe, tidy and organized laboratory environment for accurate test results.
Teacher Helper
Elementary School Ricardo Rodriguez
06.2016 - 07.2016
- Responded to student needs and questions promptly.
- Promoted a positive learning environment by effectively managing classroom behavior and addressing individual needs.
- Assisted teachers in preparing instructional materials, ensuring alignment with curriculum objectives.
- Supported teacher in monitoring students during lunch periods, recess, and other non-instructional times to maintain safety and orderliness.
- Supported classroom activities, tutoring, and reviewing work.
- Adhered to classroom protocols to keep areas clean, neat, and organized.
Librarian Assistant
High School Juan Ponce De Leon
08.2015 - 05.2016
- Supported librarians in maintaining an organized, up-to-date collection through meticulous cataloging and shelving tasks.
- Developed subject expertise on selected topics to better assist patrons with specialized research needs.
- Contributed to a welcoming library environment by promptly addressing patron inquiries and concerns.
- Streamlined circulation processes by expertly managing check-in and check-out procedures for various materials.
- Assisted librarians with collection development by providing input on emerging trends, patron needs, and usage statistics.
Education
Bachelor of Science - Microbiology
University of Puerto Rico
Arecibo, Puerto Rico01-2023
Marketing Certificate
High School Juan Ponce De Leon
Florida, Puerto Rico01-2016
Certificate of Chorister And Pianist
School of Fine Arts/Free Music of Arecibo
Arecibo, Puerto Rico01-2016
Skills
- Process flows
- Team Training
- Equipment troubleshooting
- Chemical handling
- Responsible
- Adaptability
- Punctual
- Works under pressure
- Teamwork
- Excellent use of Microsoft programs
- Quick typing
- Skill in interpersonal relationships
- Bilingual (English/Spanish)
- Decision Making
- Planning / Delegation
Additional Information
QUALITY SYSTEMS:
- SAP
- TrackWise
- LIMS
- Cara Genesis
- Microsoft Office Tools
- Decision
- Citrix
- QDA
- GDP’s
- GMP’s
- CAPA / Investigations
- D2 Reading Only
Timeline
QA In ProcessTechnician
Pfizer/Viatris
11.2023 - Current
Security Officer
T. A. Security
04.2023 - 04.2024
Laboratory Assistant
University of Puerto Rico
01.2021 - 05.2021
Merchandiser Specialist
Suiza Dairy
01.2018 - 11.2023
Teacher Helper
Elementary School Ricardo Rodriguez
06.2016 - 07.2016
Librarian Assistant
High School Juan Ponce De Leon
08.2015 - 05.2016
Bachelor of Science - Microbiology
University of Puerto Rico
Marketing Certificate
High School Juan Ponce De Leon
Certificate of Chorister And Pianist
School of Fine Arts/Free Music of Arecibo
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