Michele Hellyer, Cqa Email & Phone Number

Chicago, Il, Us

Buffalo Grove, Illinois, United States

Develop and maintain Supplier Quality program in collaboration with Nemera corporate directives. Manage the establishment, evaluation, approval and compliance for raw material and component suppliers, supporting industry leading medical device and pharmaceutical clients. Prepare, schedule and perform remote and onsite quality audits for critical suppliers. Maintain supplier documentation, specifications and quality agreements on an annual basis to support regulatory requirements. Oversee incoming inspection, collaborating with procurement to resolve nonconformances requiring corrective actions. Participate in external audits, recertifications and organizational quality initiatives.

Loves Park, Il

Lead Auditor, managing a 3 member audit team to drive compliance throughout the corporation. Responsible for managing Corrective Action System, Document Control, and Training Programs, ensuring compliance to quality objectives and regulatory requirements. Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria to drive compliance throughout the organization. • Conducts investigations and assessment for all CAR assignments, for approval or extenstion events.• Administration member for EDM, DocuSign and Training Manager. • Collaborates and reports Quality Assurance metrics for semi-annual Management Review Meetings.• Lead ISO 9001 Internal Auditor to manage, schedule and monitor all internal/external auditing activities.

Northbrook, Ilinois

Evaluation of the documentation required to ensure accurate and complete label development, evaluations, reviews, and approvals for the Latin America market segment. Ensure active adherence to the global labeling processes by ways of auditing and application of appropriate tools and systems to ensure harmonization and compliance with company and GMP standards and specifications. Manage continuous and vigilant evaluation of labelling compliance via the Labelling Change Control process and the end to end labeling process flow. Strictly following US and regional procedures. Verification of both master electronic files, as well as hard copy original artwork, HA approvals and LRT documentation.

Lake Forest, Il

Manage and collaborate with Annual Product Review teams, both domestic and international, to review and analyze data to generate comprehensive final reports. Serve as subject matter expert for CAPA and Statistical Process evaluations provided from external CMO facilities. Serve as the liaison between international business partners to ensure timely and accurate information is obtained. Demonstrate proficiencies in pharmaceutical manufacturing, packaging and specification design to support overall progression of contributor inputs.

Deerfield, Illinois

Provide program leadership for specification development in support of domestic and global market expansion. Support TPUSA and affiliate organizations documentation related to product stability, procedural compliance, metrics improvements and CAPA investiations. Secure source documents and develop specifications that are globally standardized for packaging and analytical functions. Monitor primary commododies at packaging sites to verfiy current testing requirements and expidite furture testing requirements as needed to maintain streamlined productivity and regulatory compliance.

Cary, Ilinois

Primary responsibility for Supplier Quality and Document Control for Durex Industries a leader in custom thermo solutions. Create, review and secure all controlled forms, procedures and instructions related to manufacturing to maintain compliance to GMP and ISO guidelines. Provide support to Quality Manager in establishing, implementing and maintaining the quality management system with our partnered suppliers and vendors. Initiate, expedite and record all Supplier Corrective Action Reports, working closely with Purchasing and external suppliers to elevate the quality of materials used in production. Manage the Document Control System through assignment of documents, creation of documents and collaboration on new/revised documents with all departments. Review and assess appropriateness of document changes in accordance with internal procedures.Maintain the Durex Intranet for controlled documents (add, delete, update). Support Quality Engineering function with completion of FAIR dimensional inspection, documentation and reporting. Generate weekly/monthly graphs and maintain CI initiative for internal department quality metrics. Conduct a variety of process/environmental audits. Provide technical training to other employees regarding quality systems and procedures.

Crystal Lake, Illinois

Manage all aspects of website to include web content management, photography and database uploads. Designer for all sales materials for new product launches and product updates to include: logo design, sales brochures and presentations. Domestic and international print media opportunities, including buyers guide entries, supplier/vendor listings and press releases. Manage corporate communications for all printed materials for all departments, including labeling. Established a standardized document center for specifications for all printed items and proof sheets. Manage product database for new or obsolete products, including database uploads for the website. Design and execute all social media and e-mail campaigns. Report website analytics and other reports based on marketing efforts.

Support the domestic sales force with competitive analysis and offensive marketing information. Conduct product conversion analysis to ensure financial and clinical outcomes were confirmed. Assist in the preparation for in-house or destination sales meetings (regional and corporate). Provide account specific materials for sales presentations to both administrative and clinical audiences. Skilled in product formulation functional descriptions of ingredients. Completion of detailed competitive product evaluations: function, composition, utilization and quality attributes.

Act as a liaison between manufacturing department and engineering staff for noncompliance issues or concerns. Evaluate product returns or work with legal department for field issues during incidents of product defective performance. Project manager for all external manufacturing of sharps disposal wall enclosures, brackets or floor carts. Assigned to perform process capability studies on new components, materials qualifications and mold revisions. Proficient operation of Instron and Optical Gauging equipment, including all related testing/measuring equipment. Support Quality Assurance Engineering staff with special assignments, documentation or vendor appointments. Perform audits for assembly/molding department history sheets, resin certifications and job sheets

Designed and implemented the formal OTC drug stability program, with internal and external lab collaborations. Scheduling and review of dose metric evaluations for all sterile products on a quarterly basis. Responsible for non-conformance evaluations, receiving inspections and outside vendor quality control. Authored SOP, inspection guidelines, testing development and provided training for QC technicians. Management of Master Device Files to ensure accuracy in compliance with FDA guidelines. Provide positive mentoring and direction to inspection team, empowering their individual strengths for success. Coordinator for in-house calibration program and collection for equipment/gauges needing outside calibration

Bachelors Of Science Degree

Activities and Societies: National Honor Society

Osha 10 Hour Certification- Standard Industries

Commisioning And Qualification Of Equipment/ Validation Protocol Development

Certified Iso 9001: 2015 Lead Internal Auditor