Docia Gaddis
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Docia Gaddis Email & Phone Number

Biotechnology/ Pharmaceutical/ Medical Device Industry at Azzur Group
Location: Atlanta Metropolitan Area, United States, United States 9 work roles 2 schools
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Current company
Role
Biotechnology/ Pharmaceutical/ Medical Device Industry
Location
Atlanta Metropolitan Area, United States, United States
Company size

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Docia Gaddis is listed as Biotechnology/ Pharmaceutical/ Medical Device Industry at Azzur Group, a company with 235 employees, based in Atlanta Metropolitan Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Docia Gaddis.

Docia Gaddis previously worked as Global Quality System Program Manager at Azzur Group and CAPA Manager, Quality Specialist at Mve Biological Solutions. Docia Gaddis holds Bachelor'S Degree, Biology/Biological Sciences, General from Georgia State University.

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Azzur Group

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Profile bio

About Docia Gaddis

Dynamic and meticulous Quality Assurance Professional with extensive experience in a Pharmaceutical and Medical Device GMP environment. An enthusiastic problem solver and strong decision-maker with expertise in Corrective Actions Preventive Actions, Deviations, Nonconformance, Root cause analysis, Change Management, Compliance, Post Market Surveillance reporting, BPD reporting, Inspection readiness, TUV Audit, GMED Audits, and FDA inspections. High proficiency in electronic Quality Management Systems e.g., Greenlight Guru, CATSWeb, Veeva, ComplianceWire, Blue Mountain Regulatory Asset Manager®(BMRam), JD Edwards, ZenQMS, Trackwise, Quickbase, and MasterControl..An effective analyst with 5 + years of professional experience in Information Technology hence highly proficient in professional writing, PowerPoint, SharePoint, Word, Excel, MacOS, and Numbers.What makes me stand out and my most effective strategy is to seek out opportunities to practice and apply concepts learned to real-world situations. Effectively managing the ideas(projects) from inception to implementation.

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Azzur Group
Azzur Group
Biotechnology/ Pharmaceutical/ Medical Device Industry
hatboro, pennsylvania, united states
Website
Employees
235
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9 roles

Docia Gaddis work experience

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Global Quality System Program Manager

Current

Maintain and improve the Quality System Program.Create, maintain and improve quality policies and multi-site procedures for harmonization of processes across all ACoD.Lead cross-functional Global Deviation Review meetings in pursuit of corrective actions to be applied toward process, training, or product issues.Initiate and manage continuous process.

Apr 2024 - Present

Capa Manager, Quality Specialist

* Own and support the Corrective Action Preventative Action (CAPA) process for Quality within the Quality Management System (QMS) globally.* Lead cross-functional CAPA Review Board meetings in pursuit of corrective actions to be applied toward process, training, or product issues.*Weekly tracking, trending, and reporting Quality Systems metrics.*.

Mar 2023 - Apr 2024

Quality Assurance Specialist

-Subject matter expert (SME), lead activities to maintain compliant Quality Systems processes; Deviation management, Corrective and Preventive actions (CAPA), Change Control, etc.-Led cross-functional teams to implement continuous improvements in companywide changes and CAPAs.-Coordinate Compliance & CAPA Review Board and Change Control Board.

Sep 2022 - Mar 2023

Quality Assurance Specialist-Quality Systems

Union City, Georgia, United States

-Manage the CAPA system including nonconformance reports, deviations, complaints, training, and document control.-Maintain Deviation, investigation and Complaint records in CATSWeb (eQMS) with the ability to perform trending analysis and help identify gaps-Review documentation, classify, trend deviations (event) and draft reportable Biological Product.

Aug 2021 - Sep 2022

Quality Assurance- Compliance

Union City, Georgia, United States

-Leads collaboration efforts with stakeholders to define, execute, and track pre-audit preparation (inspection readiness) tasks to meet year-round compliance goals. -Communicate quality issue identified by trends or significant events to pertinent functions across the organization. -Assists management with analyzing prior year’s audit for lesson’s learned.

Oct 2020 - Aug 2021

Quality Analyst Bioassay

Union City, Georgia, United States

  • Comprehensive knowledge and understanding of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment.
  • Responsible for performing Quantitative, Qualitative, Analytical, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality.
  • Routinely conducts monitoring, testing, SOP generation and revision, investigation, and implementation… Show more
  • Routinely conducts monitoring, testing, SOP generation and revision, investigation, and implementation of new microbiological/analytical programs as needed.
  • Assist in coordinating the preparation and conduct of study protocols, data analysis, reports, and standard operating procedures (SOPs) that support manufacturing activities and complex investigations to identify root.
  • Performs testing in support of method validation studies as assigned.
Aug 2020 - Sep 2020

Remote Technical Support Iii

- Strong technical problem-solving experience with an insightful and intuitive understanding of strategies for effective facilitation of communication among groups.-Timely supported new product introduction and existing models to sustain business globally.- As the final customer-facing representative for Apple, proficient in conflict resolution, root cause.

Jan 2016 - Sep 2022

Undergraduate Research Assistant

Atlanta, Georgia, United States

-Participate in a project investigation in comparative embryology and fish morphology via the developmental staging of different species of cichlid fish.-Initiate and conduct deviation investigations, including performing interviews, review documentation and use relevant data systems to determine the root cause.-Working on basic bioinformatics such as.

Jun 2019 - Aug 2019

Retail Store Manager

Greater Atlanta Area

-Managed projects to improve sales and revenue by reviewing previous projects, identify lessons learned and areas of improvement, and implement during the next launch.-Identify promotional opportunities and integrate them into annual marketing plans.-Developed process improvement and customer risk mitigation programs to reduce general liability risk in.

Sep 2008 - Sep 2014
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2 education records

Docia Gaddis education

FAQ

Frequently asked questions about Docia Gaddis

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What company does Docia Gaddis work for?

Docia Gaddis works for Azzur Group.

What is Docia Gaddis's role at Azzur Group?

Docia Gaddis is listed as Biotechnology/ Pharmaceutical/ Medical Device Industry at Azzur Group.

Where is Docia Gaddis based?

Docia Gaddis is based in Atlanta Metropolitan Area, United States, United States while working with Azzur Group.

What companies has Docia Gaddis worked for?

Docia Gaddis has worked for Azzur Group, Mve Biological Solutions, Immucor, Inc., Dendreon, and Apple.

Who are Docia Gaddis's colleagues at Azzur Group?

Docia Gaddis's colleagues at Azzur Group include Donald Pasayes, Mahesh Tummidi Pmp®, Clarence Noronha, Robert Mitchell, and Erin Thane.

How can I contact Docia Gaddis?

You can use AeroLeads to view verified contact signals for Docia Gaddis at Azzur Group, including work email, phone, and LinkedIn data when available.

What schools did Docia Gaddis attend?

Docia Gaddis holds Bachelor'S Degree, Biology/Biological Sciences, General from Georgia State University.

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