Wanda Alvarado
Kearny
Overview
18
18
years of professional experience
Work History
Operations Supervisor
Catalent Pharma Solutions
08.2022 - Current
Operations Supervisor
QuVa Pharma
11.2018 - 06.2021
- Maintained 100% accuracy in aseptic environmental documentation.
- Supervise staff in execution of daily work, ensure standard operating procedures, comply with validated parameters,
- Counsel, train, and develop technicians for efficient performance
- Support, Trouble shoot and resolve issues, train leads how to complete in process checks and verification
- Process improvement collaboration.
- Ensure technicians and group leaders are 100% in GMP compliance, never late on SOP trainings.
- Ensure production efficiency reduce downtime
- Meet weekly production goals in ILP
- Aseptic Processing: oversee the inspection, labeling, and packaging of produced sterile products. Injectables - surgery anesthesia & IV bags inspection.
- Aseptic experience: Experience in working in Grade A environment including aseptic qualification and performing environmental monitoring.
- Oversee the Operation and maintenance of large complex isolators, ensuring optimal performance and adherence to safety protocols.
- Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system.
- GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation.
- Cleanroom Environment: Oversee operations for Grade C conditions, maintaining good aseptic cleanroom behaviors
- Collaboration: Communicate clearly with the team and work closely with other teams to ensure on time delivery.
- Training and Compliance: Assist in training new staff on sterile operations, supply procedures and protocols, ensure adherence to GMP standards.
- Leadership: identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Organize and prioritize own work to meet shop floor priorities and identify discrepancies. Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
- Schedule Adherence: schedule adherence and maintain communication within the team. Maintain a continuous improvement mindset to increase efficiency or reduce risk to schedule adherence.
- Compliance: Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement.
- Supports investigations and implementation of corrective/preventative actions. Help identify root cause
Packaging Supervisor
Voyant Beauty
06.2018 - 01.2021
- Supervised packaging operations, ensuring adherence to safety protocols and quality standards.
- Trained team members on machinery operation and efficient packaging techniques.
- Optimized workflow processes, reducing downtime and improving production efficiency.
- Collaborated with quality assurance to implement corrective actions for packaging defects.
- Conducted performance evaluations, providing feedback to enhance team productivity and morale.
- Ensured compliance with industry regulations and company policies during daily operations.
- Maintained 100% accuracy in aseptic environmental documentation.
- Supervise staff in execution of daily work, ensure standard operating procedures, comply with validated parameters,
- Counsel, train, and develop technicians for efficient performance
- Support, Trouble shoot and resolve issues, train leads how to complete in process checks and verification
- Process improvement collaboration.
- Ensure technicians and group leaders are 100% in GMP compliance, never late on SOP trainings.
- Ensure production efficiency reduce downtime
- Meet weekly production goals in ILP
- Aseptic Processing: oversee the inspection, labeling, and packaging of produced sterile products. Injectables - surgery anesthesia & IV bags inspection.
- Aseptic experience: Experience in working in Grade A environment including aseptic qualification and performing environmental monitoring.
- Oversee the Operation and maintenance of large complex isolators, ensuring optimal performance and adherence to safety protocols.
- Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system.
- GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation.
- Cleanroom Environment: Oversee operations for Grade C conditions, maintaining good aseptic cleanroom behaviors
- Collaboration: Communicate clearly with the team and work closely with other teams to ensure on time delivery.
- Training and Compliance: Assist in training new staff on sterile operations, supply procedures and protocols, ensure adherence to GMP standards.
- Leadership: identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Organize and prioritize own work to meet shop floor priorities and identify discrepancies. Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
- Schedule Adherence: schedule adherence and maintain communication within the team. Maintain a continuous improvement mindset to increase efficiency or reduce risk to schedule adherence.
- Compliance: Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement.
- Supports investigations and implementation of corrective/preventative actions. Help identify root cause
Senior Administrative Assistant/ Master Trainer
Perrigo Pharmaceuticals
10.2007 - 08.2017
- Coordinated executive schedules, ensuring efficient time management and prioritization of key meetings.
- Managed confidential documents, maintaining compliance with industry regulations and company policies.
- Streamlined office procedures, enhancing workflow efficiency and reducing administrative bottlenecks.
- Developed training materials for new staff, fostering onboarding consistency and knowledge retention.
- Maintained 100% accuracy in aseptic environmental documentation.
- Supervise staff in execution of daily work, ensure standard operating procedures, comply with validated parameters,
- Counsel, train, and develop technicians for efficient performance
- Support, Trouble shoot and resolve issues, train leads how to complete in process checks and verification
- Process improvement collaboration.
- Supports investigations and implementation of corrective/preventative actions. Help identify root cause
- Administrative Assistant for the Manufacturing Manager.
- Monitored compliance through training record tracking systems LMS.
- Ordered manufacturing supplies drums, tote bags, gloves, tools, equipment parts, booties
- Received & monitored Raw Materials in SAP
- Assigned materials used in manufacturing of batches to the batch records
- Translated HR & Safety meetings / translated SOP trainings in Spanish
- SOP Master trainer for operations; new employees, staff updates of SOPs, warehouse personnel, and mechanics
- Reports generated via LMS for training due dates and training coordination with operations
- Order office supplies, scheduled equipment vendor visits
- Calendar keeping for Manufacturing Manager and Packaging Manager
- Paystub distribution/handout
- Responsible for Expense reports & company card
- Travel expense and itinerary coordinator
- SLT meeting minutes keeper
- Events coordinator
- Attend Process Improvement Meetings
- Incident investigations and remediation
Education
Bachelor of Science - Computer Information Systems
Monroe College
Bronx, NYSkills
- Operations management
- Performance monitoring
- Task delegation
- Staff supervision
- Team Training
- Employee development
- Production
- Quality assurance
- Compliance management
- Root-cause analysis
- Scheduling coordination
- Project management
- Operational planning
- Incident reporting
- Data analysis
- KPI tracking
- Change management
- Employee engagement
- Team leadership
- Decision-making
- Microsoft office
- Coaching and mentoring
- Staff development and training
- Leadership and change management
- Strategic planning
- Documentation and control
- Cross-functional collaboration
- Performance management
- Administrative management
Timeline
Operations Supervisor
Catalent Pharma Solutions
08.2022 - Current
Operations Supervisor
QuVa Pharma
11.2018 - 06.2021
Packaging Supervisor
Voyant Beauty
06.2018 - 01.2021
Senior Administrative Assistant/ Master Trainer
Perrigo Pharmaceuticals
10.2007 - 08.2017
Bachelor of Science - Computer Information Systems
Monroe College