SUMMARY:

• Project Management Lead to organize regulatory compliance systems quality objectives
• SQF Practitioner/Experience Certified HACCP Trained Manager and FSMA System Developer/Auditor
• Extensive Supplier Selection, Product Sourcing, Product Quality, Purchasing/Management Experience
• Provide Strategic Direction for Company Wide Facilities On Product Safety and Quality System Standards Ingredient/Pharma Safety/Inspection/Assurance Programs
• SQFI SQF Registered Lead Auditor/Trainer
• Chemical Supplier Strategic Sourcing/Quoting/Contracting
• CAPA Processing/Root Cause Investigative Actions

PROFESSIONAL EXPERIENCE:

Confidential

QA Manager

Responsibilities:

• Directly lead and organize quality objectives as it relates to regulatory compliance systems creation, development and full training implementation for all personnel (Production, QC Lab, Maintenance, QA, etc.)
• Value Added Emphasis on Strong and Passionate Professional Management Leadership and Support
• Hands On Knowledge of Quality Management/Manufacturing Systems PMP/FDA/GMP/ ISO/SQF/TS16949
• FDA Liaison with regulatory agencies visits/auditing experience, direct continuous improvement initiatives
• Strategic Direction for Company Wide Facility(s) on Product/Ingredient Safety/Quality System Standards
• Technical Training/Experience on Critical GMP Ingredient Safety and Quality Requirements in areas of HACCP, Sanitation, Pre - Requisite Programs, Allergen Control, Microbiological, Pest Control, etc. as required
• Implement CAPA/Ingredient Safety/Inspection/QA Programs/Plans, Process Controls and Mock Recalls
• Systems/Equipment/Process Validation Experience, KPI Dashboard Development Ensures a Safe, Compliant Facility
• HACCP Trained, HACCP System Developer/Auditor/Trainer, Statistical Modeling of Manufacturing Processes
• Develops Project Plans, Budgets, Goals, Objectives Accountabilities, Dates, Milestones and Reviews Defined
• Partnering/Liaison with Multi-Functional Teams to Ensure Good Team Relationships/Work, Drive Individual Accountability, Outstanding Team Work, Resolve Issues, Drive Actions to Impact Project Success
• Major Projects with Scheduled and Facilitated Project Team Meetings and Reports Status Against the Project Plan
• Proactively Work to Resolve Issues; Drive Actions to Impact Project Success and Coordinate OTD of Product
• Assist Management in Information Gathering, Research, Project Task Execution, Educate, Train, Other Activities
• Certified Six Sigma Black Belt (Focus/Achieve Measurable/Quantifiable Financial Returns from any Project)
• Retain sampling, including coloring, smell and customer/company production requirements and standards
• Supplier Support Functions: Supplier Selection/Product Sourcing/Quality/Purchasing/Management
• Supplier Quality Engineering with Chemical/Other Supplier Strategic Sourcing/Quoting/Contracting
• QA and QC Direct Reports (Environmental Monitoring Engineer, QC Lab/Micro Testing Personnel

Confidential, Indianapolis, IN

Quality Assurance Manager

Responsibilities:

• Proficient in SQF, cGMP and ISO Rules and Regulations for six contract manufacturing/warehousing/ distribution facilities located throughout the USA and Puerto Rico.
• CAPA, Food Safety and Supply Chain System responsibility throughout the companies various facilities
• FDA Liaison with regulatory agencies visits/auditing experience, direct continuous improvement initiatives
• Develop/execute SQF Plans, changes, revisions, etc. to achieve/maintain SQF Level 3/ISO Certification(s) (Such as ISO 9001, ISO 13485, ISO 17025, ISO 26262/GMP, etc./21 CFR (210, 211, 810, 820 and others) to meet requirements related to Ingredient Safety Supply Chain Management. Certifying Supplier Quality and GMP safety programs relating to Customer Supplier Requirements (Full product recognition from manufacturing point to final customer location).
• Management authority with technical response to situations where deviations or potential risks (CAPA) have occurred pertaining to the supplier chain management in relation to ISO, GMP, SQF, Other Programs
• Ability to analyze processes for HACCP (Biological, Chemical, and Physical Hazards) with a thorough understanding of the science and support behind each type of hazard and each step of a mfg./warehouse processes
• Direct and implement GMP/SQF, Prerequisite Programs, Recall, HACCP system, CAPA program, supplier chain regulatory audits, (Ingredient safety audits, assorted complaints including auditing (Internal/External) to GMP/ISO/SQF quality s and certification processes. Maintained all documents, forms, records, etc.
• Strong organizational, leadership skills and problem solving skills with the ability to work with production teams and independently in a goal standard oriented style within the organization to improve performance, effectiveness and efficiency of the GMP/ISO/SQF program (Process/Capital improvement, calibration services, etc.)
• Progressive ingredient safety and pharmaceutical experience in a contract R & D/Manufacturing environment
• Authenticate and facilitate companywide GMP/ISO/SQF/CAPA/Ingredient safety/quality related training events
• Assist/develop diversified Suppliers seeking GMP/ISO/SQF higher quality standards and registrations
• Develop manuals (system, training, user, etc.), work instructions, forms, etc. for all organization levels
• Technical Training on Critical GMP Ingredient Safety and Quality Requirements in areas of HACCP, Sanitation, Pre-Requisite Programs, Allergen Control, Microbiological, Pest Control, etc. as required
• Project Management experience entails contract manufacturing strategic development, planning, scheduling, budgeting, safety (Facility, environmental, etc.) and evaluating process capabilities
• Specialize in procurement of chemicals, value added system development/implementation, customer interface (audit/external/CAPA), vendor contact with continuous quality improvement activities
• New Product Development expertise in PMP design, development, implementation completion for contract manufacturing, distribution, customer relations, purchasing and inventory control into one integrated process
• Proficient computer skills with experience using Microsoft Office and other professional programs.