Quality Manager - ISO 9001 - CGMP - CAPA & Audits
Resume:
James (J.J.) Miller
*.*.********@*****.***
Yukon, OK
Professional Profile
A highly skilled Quality professional with over 10 years of experience across various industries, ensuring compliance with stringent quality and regulatory standards. Proven expertise in project management, supplier relationships, conducting audits, and implementing continuous improvement initiatives to enhance product quality. Adept at driving quality assurance programs, developing corrective actions, and collaborating with cross-functional teams.
Professional Experience
Quality Manager, Orbit Irrigation LLC
April 2021 – Present
● Interpreted and executed Operations Standard Operating Procedures (SOPs) to ensure compliance with ISO 9001 standards.
● Led comprehensive audits and ensured full adherence to quality standards.
● Directed the development of Corrective and Preventive Actions (CAPA) and managed projects through to successful completion.
● Analyzed customer feedback driving improvements in product quality.
● Managed supplier performance, addressing any performance issues promptly.
● Oversaw document control systems, ensuring that all policies and procedures were accurate and up-to-date..
Quality Manager, GE Nutrients, Inc. (Gencor)
November 2020 – April 2021
● Administered all Foreign Supplier Verification Program (FSVP) documentation, ensuring full regulatory compliance.
● Reviewed and ensured supplier adherence to US regulatory standards across the supply chain.
● Partnered with Operations, Shipping, and Sales to maintain quality throughout the production and delivery processes.
Quality Manager, Medical Horizons
April 2016 – April 2020, North Salt Lake, UT
● Spearheaded the administration of quality systems, embedding CGMP protocols into daily operations.
● Led qualification audits for contract manufacturers and third-party laboratories, implementing corrective actions where necessary.
● Conducted internal audits, identifying gaps in processes and driving the development of corrective actions to address these issues.
● Managed third-party manufacturers and labs including through authoring quality agreements and challenge testing of products to evaluate performance.
● Coordinated with various departments to resolve customer complaints and support sales and marketing initiatives.
● Developed monthly performance metrics, identifying areas for continuous improvement.
Quality Assurance Manager/Production Manager, BlackMarket LLC August 2013 – February 2016, West Valley City, UT
● Earned Six Sigma Green Belt certification and applied process improvements to enhance operational efficiency.
● Managed production schedules and ensured compliance with CGMP and internal quality standards.
● Supervised production teams, driving performance and meeting production deadlines consistently.
Education
Bachelor of Science in Physical Education
Minor in Spanish
Utah State University – May 2013, Logan, UT
Skills and Qualifications
● Extensive experience with 21 CFR 111 cGMPs, and ISO 9001
● Expertise in supplier audits, quality control, and CAPA implementation
● Proficient in Microsoft Word, Excel, Google Docs, and Google Slides
● Excellent communication skills with a proven ability to influence change and promote continuous improvement
● Willingness to travel and ability to work across multiple locations Key Competencies
● Quality Assurance & Compliance
● Project Management and Developement
● Supplier Relationship Management
● Risk Assessments & Audits
● Continuous Improvement Initiatives
● Cross-functional Team Collaboration
● Data Analysis & Metrics Development
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