Sandra Jeannette Cruz
Ottawa,Ontario
Summary
Sandra Cruz Ethical, ambitious, collaborative, innovative, initiative-taking and goal-oriented professional interested in continuing applying my skills in the Quality Assurance Department. My integrity, excellent academic background, and experience demonstrate I possess extensive skills in auditing Quality Management Systems, developing procedures, and performing process improvements through tools including CAPAs, non-conformance reports and trending analysis. Skilled in performing cross-functional teams, demonstrated exceptional communication skills, and performed critical decisions to ensure products meet the quality standards, regulations, and safety requirements. To seek and maintain a full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
23
23
years of professional experience
Work History
Quality Assurance Specialist
BWXT Medical Ltd.
05.2020 - Current
- Participating in revision and approval of various documentation including change requests, lot releases, manufacturing process, CAPAS, no test investigations, Deviations, nonconforming material, validation procedures and incoming material
- Auditing procedures as per Company’s Quality Management System, ISO 13845:2016 Standards, FDA, Health Canada, Nuclear Regulations and GMP regulations
- Leading and proposing strategies to improve Documentation flow, Water for Injection Management System and Parametric Release
- Identifying and documenting corrective actions to maintain the effectiveness of the Quality System
- Working with different departments to implement parametric release for Indium In-111 Oxyquinoline and improvements regarding nonconforming raw materials
- Performing change controls in response to corrective actions and process improvement
- Auditing process including In-111 Oxyquinoline product manufacturing and Product distribution
- Granted as Lead Auditor ISO 19011: 19011, ISO 13845:2016 and Nuclear Energy Employ II.
- Recorded findings of the inspection process, collaborating with a quality team to implement corrective actions.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Analyzed quality and performance data to support operational decision-making.
- Implemented process improvements to increase productivity in quality assurance operations.
- Completed deviation forms and recorded findings of the inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Monitored product standards and quality-control programs.
- Fixed identified issues to improve workflows.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Liaised with vendors and end-users to uncover system optimization opportunities.
- Conducted data review and followed standard practices to find solutions.
- Drafted technical documents such as deviation reports, testing protocols and trend analyses.
- Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
- Assessed products or services to evaluate conformance with quality standards.
Quality Assurance Supervisor
Canopy Growth Corporation, Tweed
10.2018 - 05.2020
- Measured and monitored the lot releases process through development of procedures that minimize the number of errors, while increasing the number of releases per month
- Participated in the construction of hold and re-work Standard Operating Procedure
- Mentored employees and maintained a positive work environment, promoted cross-functional teams to solve critical issues
- Audited SOP and processes, leaded the integration between the Inventory system and the Quality Management system to respond effectively to Health Canada observations
- Supported the Quality Management System performing non-conformities, plan deviations, CAPAs and OOS investigations
- Performed interviews and performance reviews, reduced the number of absenteeism through daily 15 minutes meetings and constructive feedback
- Granted as a security clearance holder under the Cannabis Regs.
- Implemented process improvements to increase productivity in quality assurance operations.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Addressed non-conformance issues, pausing production to correct errors.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Production Manufacturing Technician
Spartan Bioscience
12.2015 - 01.2019
- Manufactured external control kits for the Spartan RX CYP2C19 System and performed quality control assessments that confirm GMP compliance
- Followed company procedures reducing DNA contamination by 95 %
- Completed batch records, calibrated equipment, and managed the lab inventory, maintained, and organized logs as per GPD
- Trained new employees significantly reducing the number of errors during the manufacturing process.
- Prepared production documents such as standard operating procedures, manufacturing batch records and inventory reports.
Educational Evaluator
Ministry of Education, National Standards of Education
01.2010 - 01.2019
- Designed and implemented tools for quantitative assessment of educational models
- Collected and compiled qualitative assessments from professionals in different areas of expertise to analyze and process information
- Guide the community in solving questions or difficulties to understand or apply the evaluation policy and National Standards of Education.
- Skilled at working independently and collaboratively in a team environment.
- Self-motivated, with a strong sense of personal responsibility.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
Quality Control Technician/Quality Assurance Specialist
Canopy Growth Corporation, Tweed
10.2017 - 10.2018
- Performed 20 lot releases per week and released complex products including oils and capsules lots after a noticeably short period of training
- Developed guidelines to assist new employees in better understanding the release process
- Assisted the grow Department, post-harvest department and encapsulation department in monitoring environmental conditions
- Performed air sampling, settle plates and micro-investigations to identify the root cause of contaminants
- Created new SOPs related to capsules visual inspections, water testing, supplier qualifications and stability testing
- Developed methodologies for cleaning validation to reduce by 10% the cost of ATP swabs.
Quality Control Technician/ Production Technician
Thermofisher Scientific
12.2016 - 10.2017
- Assessed microbiological products, performed chemical, physical, and microbiological tests
- Identified causes of product contamination thought environmental monitoring conditions and data analysis
- Prepared more than 30 antibiotic solutions for microbiological products a day
- Led the Latino Hispanic Heritage and promoted diversity in the workplace
- Created team building activities involving catering, music, art, and games that positively impacted the workplace environment
- Trained personnel in GMP, GDP, and GLP standards.
- Performed thorough inspections of incoming materials and outgoing products.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Maintained quality documentation and records for conformance with relevant standards.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
- Performed routine maintenance and calibration on testing equipment.
- Created testing protocols to be used across product lines.
Chemical Technician
Drain All
04.2014 - 12.2015
- Maintained good laboratory practices during sample and chemicals test of oils, flammables, pesticides, acids, basis, propane, and paint-related materials
- Actively involved in Household Hazardous Waste (HHW) events organized by the company in conjunction with the City of Ottawa
- Led by example, impacted the team members working efficiently.
- Efficiently organized and maintained equipment to keep the laboratory productive and safe.
- Recorded test results using a variety of chemistry-specific software programs.
Animal Technician
CiToxLAB North America Laval
04.2015 - 08.2015
- Handled animals (dogs, pigs, rabbits, monkeys and, rodents) for pre-clinical studies.
- Monitoring clinical signs, dosing, and sampling according to the procedures established.
- Maintained logs as per Good Laboratory Practices and Good Documentation practices.
- Established effective communication with all personnel involved in the processes of animal handling
- Operated a variety of lab instruments and devices for pre-clinical studies.
- Restrained animals safely during exams and procedures.
- Administered medications to animals in treatment and documented changes in condition.
- Cleaned and disinfected exam areas, surgical equipment, and kennels to prevent diseases and control odours.
- Cleaned and disinfected exam areas, surgical equipment, and kennels to prevent diseases and control odors.
Science Coordinator, Biology and Chemistry Teacher
Centro Lestonnac High School
01.2000 - 01.2012
- Directed Environmental and Social projects to persuade the local communities to develop Urban Agriculture projects, Water Conserving and Reducing, Reusing and Recycle of the wastes
- Integrated the ISO 9001:, to the Educational Project of the institutions to organize and improve the quality of the educative service
- Communicated frequently with parents, students, and faculty to provide feedback and discuss instructional strategies.
- Incorporated exciting and engaging activities to achieve student participation and hands-on learning.
- Instructed students in lab by teaching safety protocols for proper use of chemicals and safe disposal of hazardous materials.
- Evaluated and revised lesson plans and course content to achieve student-centered learning.
- Prepared plans, materials and activities for students to reach chemistry learning outcomes.
- Planned and monitored implementation of technology-based learning programs.
- Designed course materials and supported implementation.
- Developed and distributed approved course syllabus to students to convey goals and outcomes of course.
- Constructed and administered tests and exams to measure student learning.
01.2003 - 01.2009
Education
Biotechnologist Advanced Diploma - Biotechnology
Algonquin College
Ottawa, ON04.2015
Specialization in Environment - Environmental and Local Development
District University
Bogota, Colombia12.2008
Bachelor of Science - Biology
National Pedagogical University of Colombia
Bogota Colombia12.2003
Skills
- Quality Assurance and Quality Control
- Management
- Team player
- Excellent time management skills
- GMP, GLP, GAP and GDP experience
- Analytical thinking
- Solving problem
- Strong systems skills (including MS Office)
- Attention to detail
- Proactive, ability to work with minimal supervision
- Lead Auditor
- Complex Problem-Solving
- Learning Strategies
- Communication and Collaboration
Timeline
Quality Assurance Specialist
BWXT Medical Ltd.
05.2020 - Current
Quality Assurance Supervisor
Canopy Growth Corporation, Tweed
10.2018 - 05.2020
Quality Control Technician/Quality Assurance Specialist
Canopy Growth Corporation, Tweed
10.2017 - 10.2018
Quality Control Technician/ Production Technician
Thermofisher Scientific
12.2016 - 10.2017
Production Manufacturing Technician
Spartan Bioscience
12.2015 - 01.2019
Animal Technician
CiToxLAB North America Laval
04.2015 - 08.2015
Chemical Technician
Drain All
04.2014 - 12.2015
Educational Evaluator
Ministry of Education, National Standards of Education
01.2010 - 01.2019
01.2003 - 01.2009
Science Coordinator, Biology and Chemistry Teacher
Centro Lestonnac High School
01.2000 - 01.2012
Biotechnologist Advanced Diploma - Biotechnology
Algonquin College
Specialization in Environment - Environmental and Local Development
District University
Bachelor of Science - Biology
National Pedagogical University of Colombia
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