Teri Bales

• Managed the Technical Service department including: o Technical reviews of artwork and structures o Review and approval of component specifications o Creation of shipping case dimensions and development of pallet patterns o Initiation, review, and approval of change controls of cGMP documentation o Hiring, training and mentoring Validation Engineers and Documentation Specialist o Equipment validation of all cGMP packaging equipment, primary rooms, and serialization equipment (FAT, IQ, OQ, PQ, Line Trials, & Engineering Studies) o Creation of cGMP documentation required to generate batch records (Packaging Instructions, Serialization Specifications, Setup Sheets, Equipment Challenges) o Creation and execution of engineering change request o Creation of Project Validations Plans • Moved artwork and component specification processing and approval to the Veratrak platform • Updated and streamlined the validation process and documents • Worked with management team to streamline documentation for use in lean batch record and created lean batch records based on the streamlined processes • Represented Technical Service Department in client meetings, provided technical reviews of project requirements, and facilitated onboarding new customers

Performed assessments for new and existing equipment and analytical instruments to determine required documentation for commissioning and qualification. Created and executed qualifications and created qualification summary reports. Developed Site Master Validation Plan

Oversaw daily quality system activities including deviations, CAPAs and Complaints. Revised, updated, and provided training for SOPs associated with quality system. Streamlined processes and forms to increase efficiency and provided quality review of equipment validations and calibrations.

In addition to all Technical Service Manager duties, added the following responsibilities: Participate in strategic planning to expand the company forward into new business areas, Provide input into process improvements, Participate in cross departmental communication activities, and Provide technical expertise to customers.

Managed the Technical Service department including. Hiring, training and mentoring associates Validation of all packaging and serialization equipment (FAT, IQ, OQ, PQ, Line Trials, & Engineering Studies) Creation of documentation required to generate batch records (Packaging Instructions, Serialization Specifications, Setup Sheets, Equipment Challenges) Creation and execution of engineering change request

Focus Environmental Provided analytical data review (data validation) for project specific quality objectives. Managed data validation projects. Served as QAO for compliance testing projects. Prepared Quality Assurance Project Plans (QAPPs). Coordinated with analytical laboratories to ensure project objectives are met. Reviewed sampling and analytical data and reporting findings for inclusion in the project reports. Provided technical assistance for various types of sampling and analytical issues. Provided assistance with hazardous materials shipping issues. Focus CVS Providing quality assurance and validation assistance for pharmaceutical packaging facilities Provided internal auditing. Assisted with nonconformance resolution and CAPAs. Created validation documents for all packaging and serialization equipment (FAT, IQ, OQ, PQ, Line Trials, & Engineering Studies) Creation of documentation required to generate batch records (Packaging Instructions, Serialization Specifications, Setup Sheets, Equipment Challenges) Provided validation assistance for facilities with computer systems regulated as medical devices. Provided quality assurance and compliance assistance, and validation activities for facilities with computer systems regulated as medical devices by FDA. (Haemonetics DMS and NextLynk). Reviewed computer system capabilities and upgrades to determine functions requiring validation. Developed validation plans to migrate from DMS to NextLynk, Developed and executed test protocols/scripts in support of validation activities. Performed reviews and updates to facility SOPs, Reviewed and updated computer system configurations and configuration documents.

Focus Environmental Provided analytical data review (data validation) for project specific quality objectives. Managed data validation projects. Served as QAO for compliance testing projects. Prepared Quality Assurance Project Plans (QAPPs). Coordinated with analytical laboratories to ensure project objectives are met. Reviewed sampling and analytical data and reporting findings for inclusion in the project reports. Provided technical assistance for various types of sampling and analytical issues. Provided assistance with hazardous materials shipping issues.

Reviewed of analytical data validation conducted by junior data validators. Performed analytical data validations (HAZWRAP & EPA-CLP) Prepared analytical data validation reports Developed sampling and quality assurance plans.