Kimberly Reed Email and Phone Number
A resourceful and versatile quality manager, with a successful record of accomplishment in quality systems, regulated environments, quality processes, client services, project management, computer system validations, compliance, continuous improvement, and operations. Possesses a proven reputation for having a genuine interest in ensuring quality and adherence to procedures. Over 25 years of experience in quality in the pharmaceutical industry serving in both auditing and management positions. Excellent customer service and relationship management skills. A proven aptitude for identifying forward-thinking solutions to improve efficiency and standardization, ensure compliance, reduce costs, and maximize productivity.
H&A Scientific, Inc.
View- Website:
- hascientific.com
- Employees:
- 11
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Quality Assurance ManagerH&A Scientific, Inc. Aug 1997 - PresentGreenville, North Carolina AreaDirect quality activities following current Good Manufacturing Practices (GMPs) and Good Automated Manufacturing Practices (GAMP) for development and release of software applications for use in FDA-regulated environments. Implement continuous improvement of quality systems to align with relevant aspects of FDA Guidance for Industry, Q10 Pharmaceutical Quality Systems. Host customer audits and complete customer questionnaires. Implemented and maintain ZenQMS for document management, training, and quality management systems. Assisted with original development and implementation of quality system.
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Director, Quality Operations SupportCuria (Formerly Amri) Jan 2021 - Jun 2023Albany, New YorkEnabled business unit’s Vice President of Quality Operations and Research and Development (R&D) to deliver strategic objectives. Supported quality heads in effective implementation of global quality standards, global procedures, and other strategic initiatives. Collaborated with cross-functional technical and operational teams across sites and global functions to monitor progress of site continuous improvement projects. Provided support to sites for inspection readiness. -
Quality Assurance ManagerCircassia Usa Nov 2018 - Dec 2020Morrisville, North CarolinaDirected quality activities including change control, complaint, CAPA, and non-conformance systems to ensure each operated in compliance with applicable regulations and standards. Created and revised SOPs to maintain Quality System compliant to FDA 21 CFR Part 210 / 211 / 11 / 820, ISO 13485, and other applicable regulatory requirements. -
Associate Director, It EcomplianceMayne Pharma Jul 2017 - Oct 2018Greenville, North Carolina AreaManaged compliance processes for cGMP computer systems and Information Technology (IT) infrastructure. Ensured cGMP regulatory and data integrity requirements were met including requirements for 21 CFR Part 11. Directed computer system validation activities and managed continuous improvement efforts. Provided quality oversight for cGMP computer systems, including change control, CAPA, deviations, and audits. -
Associate Director, Quality SystemsMayne Pharma Oct 2015 - Jul 2017Greenville, North Carolina AreaOversaw compliance processes for cGMP computer systems and IT infrastructure. Ensured cGMP regulatory and data integrity requirements were met including requirements for 21 CFR Part 11. Directed computer system validation activities and managed continuous improvement efforts. Provided quality oversight for cGMP computer systems, including change control, CAPA, deviations, and audits. Served as system administrator for MasterControl electronic document and training management system.
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Associate Director, Quality AssuranceMetrics, Inc. Jan 2013 - Oct 2015Greenville, North Carolina AreaProvided oversight of quality systems. Supervised release process for commercial and Clinical Trial Material (CTM), including analytical release of commercial, CTM, and stability data. Conducted internal and supplier audits. Hosted and supported client audits and regulatory (FDA, MHRA) inspections. Prepared QA monthly reports and management review slides. Served as system administrator for MasterControl electronic document and training management system. Managed compliance processes for cGMP computer systems and IT infrastructure. Ensured cGMP regulatory and data integrity requirements were met including requirements for 21 CFR Part 11. Directed computer system validation activities.
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Senior Quality Assurance ManagerMetrics, Inc. Mar 2012 - Dec 2012Greenville, North Carolina AreaCompleted same responsibilities as Quality Assurance Manager, with increased focus on quality client relations (client audits and quality agreements).
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Quality Assurance ManagerMetrics, Inc. Jan 2003 - Mar 2012Greenville, North Carolina AreaProvided oversight of analytical quality systems. Supervised analytical release process for Clinical Trial Material (CTM) commercial and stability data. Coordinated training program documentation and conducted initial and annual GMP training. Administered computer system validation activities for cGMP computer systems and for IT-based platforms supporting cGMP operations. Hosted client audits and responded to observations. Hosted and supported regulatory (FDA, MHRA) inspections. Conducted internal and supplier audits. Participated as core team member supporting selection, configuration, validation, and implementation of Empower chromatographic data system.
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Quality Assurance SpecialistMetrics, Inc. Jul 2001 - Jan 2003Greenville, North Carolina Area
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Quality Assurance AuditorMetrics, Inc. Jan 1998 - Jun 2001Greenville, North Carolina AreaReviewed analytical data reports and supporting documentation including deviations and investigations to assure compliance with current Good Manufacturing Practices (GMPs). Released active pharmaceutical ingredients, raw materials, and equipment following cleaning verification. Reviewed batch records and released commercial and CTM product. Reviewed and approved SOPs, analytical methods, and qualification protocols. Conducted internal audits and supported client audits and regulatory inspections. Assisted with software and spreadsheet validation. Served as backup administrator for sample management system.
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Laboratory AnalystMetrics, Inc. Oct 1996 - Jan 1998Greenville, North Carolina AreaAnalyzed and reported results for GMP laboratory analyses for client products including HPLC assay, dissolution, and Karl Fischer moisture.
Kimberly Reed Education Details
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Biochemistry
Frequently Asked Questions about Kimberly Reed
What company does Kimberly Reed work for?
Kimberly Reed works for H&a Scientific, Inc.
What is Kimberly Reed's role at the current company?
Kimberly Reed's current role is Experienced Quality Professional | Quality Systems | Computer System Validation | Project Management | Client Relations | Driving adherence to procedures and ensuring quality processes for successful outcomes.
What schools did Kimberly Reed attend?
Kimberly Reed attended University Of North Carolina At Chapel Hill, East Carolina University.
Who are Kimberly Reed's colleagues?
Kimberly Reed's colleagues are Mark Cheshire, Michael Holland, Amy Hudson, Philip Cash.
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