Reina Zuliani

Grovetown, GA. 805-***-**** ad115j@r.postjobfree.com

Summary of Qualifications

Versatile, hardworking, results-oriented, and self-motivated QA Professional with transferable skills, extensive in quality assurance, quality management systems, CAPA investigations, and manufacturing processes leadership within the pharmaceutical industry

Quality Assurance

Project Management

Leadership & Teamwork

Auditing

Process Improvement

Employee Training & Mentorship

Safety Regulations

Manufacturing Processes

Time Management

Technical Support

Troubleshooting

Interpersonal Skills

Inventory Control

Data Analysis

People Manager

PROFESSIONAL EXPERIENCE

Multi-Site Manager, Quality Assurance Dura-Line, Sandersville, GA

August 2022- Present

Accountable for 2 fully operational Quality Laboratories, compliance for TL9000 and ISO9001 regulations. Managed 12 full time employees and 3-5 temporary employees. Established strong quality mindset throughout the Dura-Line facilities. Trained additional facility quality managers in expectations for compliance, auditing and testing protocols. Rolled out a new corporate designed QMS system for implementation across all functional areas.

Key Contributions

Onboarded brand new Quality Lab, Environmental Recovery Project

Created Validation processes for production operations

Audit Lead (TL9000/ISO9001)

Responsible for closing Customer Complaints and Deviations, (Reduced 17 overdue to Zero since onboarding). Minimized occurrence of complaints, through strong root cause analysis and corrective actions.

Manager, Quality Engineering and Supplier Quality Anteris Management Consulting, Alpharetta, GA

June 2021- August 2022

Oversaw and ensured the successful day-to-day quality operations of 6 Clients and 4 Distribution Centers of manufactured medical devices. Provided customer facing support for superior quality compliance. Was responsible for client project management providing oversite of deviations, CAPAs, and change controls impacting the client products, providing management on quality guidelines and regulations, adherence to Quality Agreements, and disposition of product. Acted as a liaison between the client and sub-groups of Quality Assurance/Engineering during establishment of new products; ensuring development of process adhered to applicable regulations.

Key Contributions:

Designed, developed and implemented a Change Control Board (CCB); to drive continuous improvement

Onboarded and qualified new distribution centers from pre-ISO regulated to compliant through ISO9001 and ISO13485 requirements (Auditing )

Established a timeline for non-conformance investigations, along with metrics tracking (KPIs)

Collaboratively developed and optimized a Documentation Control Process/QMS for compliance and reliability

Manufacturing Supervisor Takeda Pharmaceutical Company, Social Circle, GA 2018 -June 2021

Complete all daily production functions including training and onboarding employees, providing company expectations to staff, planning and monitoring performance, and enforcing company policies and procedures. Enforce quality assurance by adhering to GMP and EH&S standards. Transfer new processes into manufacturing methodologies, identify faults in processes, and cooperate with Engineering and Quality departments to resolve equipment, process, and compliance issues. Develop and manage the performance of 17 direct reports.

Key Contributions:

Reorganized production task times by setting specific schedules for tasks, creating higher overall yields in production using KPIs, and trending.

Interim department lead, coordinating scheduling, material transfers, and maintenance.

Performed internal and external audits with internal and external clients, including FDA.

Consistently achieved company objectives by participating in technical reviews, investigations and process improvement projects.

Quality Assurance Specialist Takeda Pharmaceutical Company Covington, GA

2016 to 2018

In consecutive roles, planned, performed, and oversaw numerous inspections and tests for products, outlined quality assurance policies and procedures, and conducted real-time reviews for behavioral observance and manufacturing documentation; guaranteeing the accurate interpretation and compliance to QA, GMP, and SOP standards. Collaborated with the Production Supervisor, Quality and Engineering personnel, and various departments to accomplish tasks, influence change management, and advance the company by way of consistent validations, operational management, EBM support, and warehouse maintenance. Inscribe, review and revise SOPs.

Key Contributions:

Managed JD Edwards and Inventory Management System from a quality standpoint.

Trained the Frac manufacturing team on effective GMP/GDP standards and the accurate usage of multiple platforms such as Electronic Batch Management and JDE navigation.

Functioned as a Trackwise 8 Quality Approver during events and CAPA investigations.

Designed a successful hand-over-procedure to the Document Control Department for manufacturing documentation related to production.

Implemented approved corrective action plans after developing strategies to accurately identify non-conformance issues.

Created and updated quality related Manufacturing SOPs.

Acquired strong understanding of the Fractionation Process.

Quality Analyst Takeda Pharmaceutical Company, Thousand Oaks, CA

2014 to 2016

Managed numerous daily quality operations pertaining utilization of plans to assess functionality, performance, reliability, stability, and compatibility of various software and systems during QA inspections. Performed batch record reviews and observation and component verifications, identified SOP derivatives, and suggested solutions to repair defects identified on the manufacturing floor; ensuring that all product specifications and packaging adhere to industry and company standards. Generated comprehensive reports that detail techniques utilized, results obtained, and solutions to said results.

Key Contributions:

Streamlined processes and maintained compliance followed the successful recommendation of documents essential to the smooth flow of operations.

EDUCATION

Bachelor of Arts, Biology, 2014 California State University Channel Islands, Camarillo, CA

TECHNICAL PROFICIENCIES

Software:

JD Edwards, Trackwise 8, LIMS, BPLM, VEEVA, EBM, SABA, ODEN, SAP, QT9

Regulations:

Good Manufacturing Practices (GMP), FDA, Good documentation Practices (GDP), ISO 9001, ISO 13485, TL9000

References:

Mira Casillas/Miller, Coworker, Takeda Pharmaceutical Company, 805-***-****

Chris Henry, Project Manager, Anteris Consulting, 865-***-****

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