Angie Rubio

• Supported successful product launches by validating manufacturing processes, equipment, and utility systems in a timely manner.
• Ensured compliance to industry standards by executing detailed validation protocols and generating comprehensive reports.
• Enhanced production efficiency with timely maintenance, calibration, and troubleshooting of validation equipment.
• Contributed to continuous improvement initiatives by identifying opportunities for process enhancements within the validation department.
• Developed customized testing procedures tailored to unique equipment specifications, ensuring accurate results throughout the validation process.
• Developed, implemented and maintained yearly schedule for required temperature mapping profiles.

Accomplishments and Special Projects:

• Certificate of Appreciation for key support and excellent execution for product NDA submission.
• Spot Award for completion of 96 protocol project within timeline
• MVP Award for contribution of enhancement of company ability to meet objectives, resulting in cost savings, elimination of waste and improved efficiencies.
• MVP Award for point of contact for marketing department to meet company objectives.
• MVP awarded for implementation of new dedicated facility line center including manufacturing line equipment ahead of schedule and under budget.
• SPOT Award for playing pivotal role in qualifying production line in response to manufacturing needs to avoid product delivery delays.
• MVP awarded for Safety awareness implementation plan.

• Reviewed and approved technical reports, demonstrating strong attention to detail and commitment to quality assurance standards.
• Maintained an up-to-date understanding of relevant industry guidelines such as FDA regulations or GAMP standards to inform daily duties.
• Served as a subject matter expert in validation principles, providing valuable insights into industry trends and best practices for client benefit.
• Conducted thorough audits of validation protocols, ensuring adherence to industry standards and best practices.
• Managed multiple concurrent projects successfully, delivering high-quality results within tight deadlines.

Generate and execute protocols to validate all equipment associated with New manufacturing fill line for multiple fill volumes for multiple product codes. Creation of Quality and deviation standards per CAPA system Managed project engineers, conducted weekly meetings assessed goals and milestones of project team.

· TL Filler IQ/OQ, and PQ, for glass and plastic bottles and vials

· PLC TL Filler Operating System RS Logix 5000 IQ/OQ and PQ

· Genesis/ West Capper IQ/OQ and PQ

· PLC Genesis/West Capper Operating System RS Logix 500 IQ/OQ and PQ

· APP Fabricated Vial Washer/ Dryer IQ/OQ and PQ

· PLC Vial Washer/ Dryer Operating System RS Logix 500 IQ/OQ and PQ

· Reports for protocols listed above

· Other duties included weekly project meeting, creation of SOPs for new equipment, preventative maintenance scheduling, Utilities, and facility assessments

Writing and executing Installation, Operation and Performance qualification protocols for the following

· Blow/Fill/Seal(BFS) machines SIP/ CIP, operating systems, and fill qualifications

· Manual Cleaning Validation/ creation of procedures

Determination of product contact

Materials of construction

Dedicated equipment vs. change over equipment

Residue Testing, Swabs, and rinsing

TOC, PH, Conductivity

Calculations and reporting of results

· Isolators

Cleaning Validation/ hydrogen peroxide wash

· Doboys

· Molds

· Alarms

· Tanks, Mixers

· Environmental Qualifications (HEPA, Climet, HVAC, micro)

· Deflashers

· Ink Jet Printers/

· Controls (Siemens, Barber Coleman Allen Bradley, Johnson, Rockwell etc.)

· Process Qualifications.

· Utilities, North Steam loop and generator

· Creation of Quality documents, CAPA assessments based on results of process filling qualifications, Creation of Standard Operating Procedures, (processes and equipment), Functional requirements and equipment specifications, Bio-burden and TOC testing for new clean steam line,

Accomplishments and Special Projects:

· Completed 178 protocols at Cardinal Health Woodstock.

· Shutdown June 05: Coordinated and conducted the Environmental Testing Project to restore 19 manufacturing rooms to Class 10,000 after floor and ceiling replacement. All rooms were back in production by 1 August 05.

· Managed FDA remediation project: The writing and execution and planning of Concurrent Fill Qualifications for 35 different products.