Quality & Operations Executive - Manufacturing, QA, FDA/USDA

Daniel M. Waite

Wautoma, Wi. ***** 920-***-**** ***************@*******.***

Quality And Operations Executive

Successfully lead processes innovation, improvement, and quality in manufacturing operations Expert operations, quality management, procurement, medical device, and food safety professional with extensive experience in laboratory and manufacturing operations following state and federal regulations. Lead negotiator, communicator, and process trainer. Executive Management Team member for onboarding project preparation and strategic business management. Successfully develop and implement divisional FDA/USDA food safety/quality plans/HACCP plans. Maintain DMF/DHF for FDA 820 compliance. Lyophilization process development of API 503b drugs for sterile vial filling. Highlights of Expertise

• Strategic Business Planning

• Cost Reduction and Avoidance

• Regulatory Compliance Authority

• Process Improvement

• Project Planning

• Budget Administration

• Develop/Perform IQ/OQ/PQ for new production

equipment.

• Operations Optimization

• Vendor Qualification and Material

Management

• Vendor Liaison

• Staff Development

• Chemistry Analysis, Analytical Chemist

• Food Safety Programs

Qualifications

• Process redesign, waste reduction, efficiency development, improvement, and implementation.

• Serve as protocol developer and federal guideline compliance champion (FDA, USDA, SQF, NSF, BSI, etc...). Product/vendor approvals and disqualifications processing. Comprehensive project management, from conception to completion. Ensure testing data uniformity to approved product specifications and product application design. Management of initial quality and quality control continuous improvement for a CDMO.

• Build complete Quality Management and Food Safety Programs to include creating and implementing Standard Operating Procedures, work Instructions, setting raw material specifications, developing process controls statistically, validating finished product acceptance limits, and training staff to competency. Data analysis via SPC data plotting, dashboard and trend reporting. Develop process preventive controls and Food Safety Plans. Laboratory, Production, Quality, and Sanitation verification and validations. Standard Process development and training in all critical processes.

• Rebuild failing and non-compliant EQMS/Good Manufacturing Process quality systems to comply to state and federal standards. Perform gap analysis of Quality Systems, and risk analysis by matrix profile. Perform root-cause determination and chemical/biological/physical analysis for product safety failure verification utilizing accepted scientific references and 3rd party ISO 17025 certified laboratories.

• Customer and vendor audit leader to include onsite/offsite inspections. Vendor data review for vendor approvals, vendor qualification compliance scoring and reporting. ISO 17025 lab auditing for qualification and compliance to regulations. Consumer complaint investigation and resolution SME. Train/oversee Document Control Coordinator and Recall/Mock Recall Coordinators. Maintain all training records for employees, flex employees, and contractors for regulatory compliance.

• Export document preparation for exporting food, supplements, and medical device finished products to Canada, the Middle East, and South America. Work with Federal inspectors, customer service coordinators, and Seaboard exporters to ensure timely, safe delivery of exported finished products.

• Plant Safety committee chair, training and interaction with new employees. Oversee and schedule waste removal via MRB (hazardous and non-hazardous determination) and pest control. Manage sanitation crew for effective plant cleaning.

• Analytical Chemist performed Nucleotide and drug assay analysis via HPLC, GC, Mass Spectroscopy, NMR, ICP, and FDA micro BAM/AOAC methodologies. Performed protein purification via FPLC and molecular sieves.

Career Experience

Attwill Medical Solutions, LP Lodi, Wisconsin

VP Quality (2022 – Present)

Dawn’s Foods, Portage, Wisconsin

VP Quality, Food Safety, and Training (2018 – 2022) Richelieu Foods, Beaver Dam, Wisconsin

Quality Assurance Manager (2014 - 2018)

Milk Specialties Global, Wautoma, Wisconsin

Quality Assurance Manager (2012 – 2014)

W-9, Wautoma, Wisconsin

Formulation/cGMP Compliance Contractor (2010-2012) Atrium, Inc., Wautoma, Wisconsin

Laboratory/Operations Manager (2005 – 2009)

Pharmacia Biotech, Milwaukee, Wisconsin

Senior Quality Control Chemist (1991 – 1997)

Covance, Madison Wisconsin, Abbott Labs, North Chicago, Illinois, Aldrich Chemical, Sheboygan Falls, Wisconsin, Wisconsin Pharmacal Jackson, Wisconsin

Contract Chemist/Quality Manager (1989-1991, 1997-2005) Education & Credentials

University of Wisconsin-Stevens Point, Stevens Point, Wisconsin BS Carthage College, Kenosha, Wisconsin

Professional Development

• Ongoing online FSMA and Food Safety/Transportation educational Webinars Certifications

• Advanced HAACP Certified International HACCP Alliance for Food Safety

• Certified SQF Practitioner SQF 9 Siliker

• PCQI Implementation Lead for FSMA, Alchemy Associates

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