Quality Assurance Document Control

April Bond

*** ******** **., ******, ** *****

919-***-**** ***********@***.***

QUALITY SYSTEMS & OPERATIONS PROFESSIONAL

Versatile quality and compliance expert with 20+ years of experience in quality system management, regulatory compliance, document control, internal/external audits, CAPA, training, and manufacturing investigations. Proven leader in managing teams and operations within GMP-regulated industries.

CORE COMPETENCIES

• Quality Assurance & Compliance (cGMP, GCP, GLP, ISO)

• Regulatory Documentation & Submissions

• Internal & External Audits

• SOP Development & Training

• CAPA/Deviation Management

• Document Control & Change Management

• Real Estate Operations & Property Management

• FDA Regulations (21 CFR Parts 11, 50, 54, 56, 99)

PROFESSIONAL EXPERIENCE

A New Way Home, LLC – Durham, NC

*Owner / Operations Manager* (2007 – Present)

- Founded and manage real estate investment and property management firm.

- Oversee property acquisitions, renovations, tenant relations, and accounting for 14 rental units.

- Handle all financial and operational aspects of the business.

KSE Scientific – Durham, NC

*Quality Systems Manager (Consultant)* (Aug. 2017 – Jan. 2018)

- Established and implemented quality procedures and documentation controls.

- Led internal audits and ensured manufacturing processes met national and international standards.

- Authored SOPs, trained staff, and initiated efficiency improvements.

KBI BioPharma – Durham, NC

*Manufacturing Compliance Review Associate* (Apr. 2014 – Aug. 2015)

- Reviewed and audited batch records, manufacturing documents, and floor operations.

- Contributed to CAPA and deviation investigations, and updated controlled documents.

Cytonet LLC – Durham, NC

*Quality Assurance Specialist (Consultant)* (Nov. 2012 – Apr. 2014)

- Implemented QA programs, vendor qualification, and SOP development.

- Managed internal audits, CAPAs, deviations, and raw materials testing programs.

Tranzyme, Inc. – Durham, NC

*Document Control Manager / QA Specialist (Consultant)* (May 2008 – Mar. 2013)

- Built in-house quality systems and managed document control.

- Conducted audits, regulatory training, and maintained compliance documentation.

EDUCATION

- B.A. in Business Organization Management (In Progress) – Ashford University

- A.A. in Business Administration – Piedmont Community College (Dean’s List)

TECHNICAL SKILLS

- MS Office Suite QuickBooks Peachtree Medisoft Misys Medix IDX

- Strong knowledge of 21 CFR compliance and regulatory guidelines

- ASQ Member Experienced in validation and submission documentation

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