Serena Patel Email & Phone Number

Longmont, Colorado, United States

Qualified Auditor• Plans and performs Internal Audits• Facilitates Client & Regulatory Audits• Collaborates with cross-functional team to remedy compliance issues

Boulder, Colorado, United States

Change Control Program Owner • Created the Change Control Review Boards (CRB) for Boulder and Longmont, CO sites• Facilitates CRB• Monitors change controls to ensure on-time closure.• Tracks metrics on the change control program to ensure the health of the quality system.• Generates and maintains SOPs and other GMP documents as needed to support the program.• Collaborated with Automation to generate the automation change management programAdditional Quality System Experience• Corrective Action Preventative Action (CAPA) management skills used to develop and execute effective plans with a multidisciplinary team• Reviewing quality system gaps, redundancies and errors with CAPA owners about process issues• Writing, investigating, and analyzing non-conformances, working with the team to determine appropriate root cause, impact, and corrective action implementationAccomplishments:• Collaborated with validation to establish the CSV program• Reduced average cycle time for CCs by 87% within 6 months mitigating risk of aging records in the Quality System

Boulder, Colorado

Computer Systems Validation• Developing and managing the computer systems validation program specifically targeting Data Integrity (as defined by ALCOA), 21 CFR Part 11 and ICH Q7 compliance• Data Integrity Project Lead - Assessed all computerized systems for compliance gaps - Identified remediation plan for any gaps found - Coordinated remediation activities schedule and execution plan with system owners and other cross-functional team members • Implementing GAMP 5 for process improvement Controlled Spreadsheet Program Owner• Developed the program to meet GAMP 5 guidance requirements around controlled spreadsheets used to support QC methods, and calculations used in the MFG process. FDA Audit Experience (Aug 2019, Aug 2020)• Due to the project planning, execution, and completion of the Data Integrity and 21 CFR Part 11 remediation efforts, no observations were made and no warning letters were issued.Validation and Qualifications• Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) generation, execution, review, and approvalQuality System Experience• Corrective Action Preventative Action (CAPA) management skills used to develop and execute effective plans with a multidisciplinary team• Reviewing quality system gaps, redundancies and errors with CAPA owners about process issues• Analyzing non-conformances, working with the team to determine appropriate root cause, impact, and corrective action implementation

Boulder, Colorado

Computer Systems Validation• Developing and managing the computer systems validation program specifically targeting Data Integrity (as defined by ALCOA), 21 CFR Part 11 and ICH Q7 compliance• Implementing GAMP 5 for process improvement FDA Audit Experience (Feb 2018) • Due to the project planning, and execution of the in-progress Data Integrity and 21 CFR Part 11 remediation efforts, no observations were made and no warning letters were issued.Validation and Qualifications• Completing calibration and quality review of assets • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) generation, execution, review, and approvalQuality System Experience• Corrective Action Preventative Action (CAPA) management skills used to develop and execute effective plans with multidisciplinary team• Reviewing quality system gaps, redundancies and errors with CAPA owners about process issues• Analyzing non-conformance, working with team to determine appropriate root cause, impact, and corrective action implementationControlled Temperature Unit (CTU) Temperature and Humidity Mapping process owner (2017)

Bangalore, India

• Working with the Solutions Team to develop and implement a documentation strategy and quality system which can be integrated into existing processes• Developing documentation templates• Evaluating risks and determining mitigation strategy in order to improve prototype designs by developing pFMEAs for smart technology solutions• Preparing Functional Design Specifications, Configuration Specifications, and testing protocols• Preparing internal SOPs (i.e. Good Documentation Practices, Training, Installation)• Developing User Manuals for existing solutions (i.e. Maintenance, Troubleshooting)• Training the Solutions, EDU, and Data Teams on new responsibilities with regards to documentation and testing processes

Centennial, Co

• Leads validation communication with the customer for pharmaceutical and medical device projects• Developed process flow diagrams that integrate validation benchmarks with project milestones to increase cross-functional team harmonization throughout the project life cycle• Created an internal tool using VBA in Microsoft Excel and Microsoft Word to optimize the validation process by reducing total functional test develop time by 1/3 of the total time • Manages validation acceptance testing for projects by coordinating all validation (installation, functional and performance) evaluations with the technicians, and various engineering groups• Trains and advises new department members throughout the validation process• Trains clients, technicians, and various engineering groups on SOPs related to Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)• Conducts tests and inspections to evaluate the safety, quality, and performance of production lines for customer products in the medical device/pharmaceutical industry• Prepares, manages executions, and approves validation protocols, test reports, and change control records• Evaluates risks and determines solutions to mitigate risks to customer products during the assembly process by developing Process Failure Modes and Effects Analyses (PFMEA)• Prepares Functional Design Specifications, Configuration Specifications, and Factory Acceptance Test protocols

Aurora, Colorado

• Validation lead for medical device projects• Lead validation communication with the customer• Coordinate and manage validation acceptance testing for projects by coordinating all validation, quality, and safety evaluations with the technicians, and various engineering groups.• Conduct tests and inspections to evaluate the safety, quality, and performance of production lines for customer products in the medical device/pharmaceutical industry.• Prepare, execute, and approve validation protocols, test reports, change control records.• Evaluate risks and determine solutions to mitigate risks to customer products during the assembly process by developing Process Failure modes and Effects Analyses (PFMEA)• Prepare Functional/Design Specifications, Configuration Specifications, Factory Acceptance Test protocols• Create internal tools to optimize the validation process (i.e. document and test templates)• Develop process flow diagrams that integrate validation benchmarks with project milestones to increase cross-functional team harmonization throughout the project life cycle.

Aurora, Colorado

• Reviewed and Finalized Validation Protocols in preparation for execution• Prepared and executed validation protocols• Managed acceptance testing execution• Developed and reviewed Functional Specifications, Configuration Specifications, User Requirement Specifications, Process Failure Modes and Effects Analyses (PFMEA), Factory Acceptance Testing (FAT) Protocols, System User Manual

Centennial, Colorado

• Researched industry competitors, brand customers, and white papers to optimize TAAZ’ new image and messaging• Utilized Google Analytics, Insights, Trends, and Adwords to optimize the keyword list associated with the company website

Greenwood Village, Colorado

• Conducted market research of the airline industry, design and content contributions, data organization and input of airline, credit card, rental car, and hotel loyalty programs • Promoted the company and the social networking identity through various social media (e.g. Facebook, Twitter, Blogs)

Littleton, Colorado

• Assisted with Clean Room Quality Assurance activities for various payloads (i.e. satellites) these activities included completing wire inspections and schematic checks.• Conducted tests and analysis of hazards and risks of a new proprietary pneumatic/hydraulic off-load testing system with team• Developed and reviewed Functional Failure Modes and Effects Analyses (FFMEA) and Standard Operating Procedures (SOP) for a new proprietary testing system and for the Engineering Propulsion Lab and Electrical Manufacturing Facility • Participated and observed in proprietary Test, Design, Ordinance and Systems Engineering tests and procedures

Littleton, Colorado

• Coordinated with Agilent Technologies regarding their equipment to update the production process following extensive research of new technologies for the production line of the facility• Tested and catalogued diode samples from multiple batches, stress tested quad flat packs in the Failure Analysis Lab

Bachelor Of Science (Bs), Mechanical Engineering, Minor In Management

Activities and Societies: South Asian Student Alliance, Society of Women Engineers, Invisible Children United at Purdue, Purdue Leaders.

Executive Mba