Leonela Herrera

• Assist in developing formulations for flooring through research, collecting data, and performing tests utilizing ASTM, ANSI, and ISO’s.
• Ability to develop cementitious formulations for flooring and tile products.
• Ability to conduct tests using ASTM, ANSI, ISO.
• Able to follow step by step directions.
• Collect, document, and store data as well as understand and interpret data.
• Able to plan work projects in accordance with production and laboratory requirements.
• Communicate effectively with supervisor, manager, and other coworkers.
• Great verbal and written communication skills.
• Great critical thinking skills.
• Excellent quality skills.
• Excellent analytical skills.
• Ability to calculate figures such as percentages.
• Ethical, diversity, organizational, and professional skills.
• Ability to use Word, Excel, PowerPoint, Outlook, and virtual meetings

Review batch records for compliance and accuracy using Standard Operation Procedures and current Good Manufacturing Practices.

• Review batch paperwork to ensure compliance with Standard Operating Procedures and Good Manufacturing Practices.
• Submit batch records to Batch Release for final approval.
• Retrieve records to assign to lines.
• Tracks a status of paperwork.
• Make corrections and train employees on errors found on paperwork for growth and development of individuals.
• Have good analytical and problem-solving skills.
• Excellent math skills (add, subtract, multiply, and divide).
• Ability to create, change, release, and assign orders, in Production Order Management System and System Application Processing.
• Ability to close records and consume materials both in POMS and SAP.
• Correct history in POMS.
• Provide support to Quality.
• Comply with all safety regulations and conduct all activities in a safe, effective manner.
• Apply Good Manufacturing Practices (cGMPs) in all areas of responsibility.
• Knowledge of Microsoft Office and excel.
• Detail-oriented and self-motivated.
• Retrieve additional reports/paperwork needed for batch records.

Set up and operate production lines following standard operating procedures and good manufacturing practices.

• Operate high-speed equipment for the manual or automated assembly, filling, packaging and labeling of pharmaceutical products with codes: ensuring adherence to specifications.
• Certified for a Senior Certified Operator (SCO)- Responsible for verifying correct information of product code and paperwork before releasing line.
• Conduct hourly Quality in-process inspections according to Acceptable Quality Level (AQL) and reconcile incoming and completed components and products to ensure accuracy and accountability.
• Clean packaging rooms and machinery in accordance with Standard Operation Procedures (SOPs) and cGMPs.
• Conduct set-Ups, in-process actions, data entry, and other computer-related tasks.
• Complete batch records accurately and document production volumes in accordance with SOPs, CGMPs and Engineering change Request/ Engineering Change Order (ECR/ECO).
• Accept or reject products according to acceptability standards determined by cGMPs, customer requirements, and SOPs.
• Complete Line Clearance and Changeovers on production lines in accordance with SOPs and cGMPs.
• Perform other duties as assigned by lead or supervisor such as floating (act as a lead to help complete setup lines on time and to meet daily production goals).
• Inspect product received from prior manufacturing stage for accuracy.
• Inspect intermediate and finished products as required.
• Maintain a smooth flow of production as required.
• Escalate in timely manner any equipment or process variances.
• Knowledge of Microsoft Office, excel, and System Application Processing (SAP system), required to be able to set up lines.
• Knowledge in working in an Aseptic Production environment.
• Non-Aseptic Gowning Certify
• Work independently to provide quality assurance oversight for manufacturing processes, inspection, labeling, packaging, batch record review and disposition.
• Evaluation and release of batches and products for compliance with defined specifications.
• In-line product testing for Nitrogen, Oxygen and Burst test.
• Detail-oriented and self-motivated.
• Excellent hand-eye coordination and manual dexterity.
• Ability to interpret work instructions and standards of work independently.
• Ability to train and lead other coworkers and new employees.
• Ability to work in multiple lines and departments.
• Performs weekly cleanings for Gel department in the fill room.
• Fill technician.

• Greeted customers and helped with product questions, selections, and purchases.
• Maintained clean and organized store environment, enhancing the overall shopping experience for customers.
• Helped customers complete purchases, locate items, and join reward programs.
• Handled returns and exchanges professionally, resolving customer issues while adhering to company policies.

• Responsible for assisting Allergan/Abbvie employees to run production lines after setup.