Marcus Muffley Email & Phone Number

Bend, Oregon, Us

• Project manager for all aspects of the GMP manufacturing expansion including management of contractors, design firms, consultants, and internal stakeholders. • Develop and align the project teams throughout each project to ensure all aspects of the project are on-time, on-budget, and of the highest quality standards possible.• Maintains internal and external stakeholder agreement and buy-in to keep the project schedule on-track.• Responsible for communicating project updates and deliverable status to all impacted personnel.• Ensure all project documentation is completed and aligned to maintain GxP standards, including FDA 21CFR Part 11 data integrity requirements.

Waltham, Ma, Us

• Project manager and SME for implementing the GMP pharmaceutical manufacturing site’s first computerized maintenance management system (Maximo).• Responsible for coordination/reconciliation of all GMP Manufacturing, Quality Control and R&D equipment; consisting of over 1350 qualifications, calibration, and maintenance events annually.• Management of vendor quality approval, scheduling, and review of executed calibration certificates and reports.• Review and approval of all GMP work orders for all GMP maintenance events.• Responsible for generating all capital asset requests for the site and maintain strategic budget. 2021 consisted of 48 capital asset requests totaling over $11.8 million USD.• Site representative for client audit inquiries regarding maintenance management and processes.

Scottsdale, Arizona, Us

• Developed, implemented, and updated best practices to streamline operations, standardized processes, and enhanced customer service.• Responsible for 25 supervisors’ overall performance and coaching.• Ensured swift resolution to team issues while complying with company policies.• Updated leadership team weekly on the company’s performance metrics and trending, and forecasting.• Trained, inspired, and rewarded a team of customer service supervisors to further company goals and sustain high customer service benchmarks.

Washington, Dc, Us

• Managed and resolved operations issues in the facility including safety incidents, disagreements between employees, scheduling/planning and last-minute decision making.• Ensured staff members adhere to established policies, procedures in cGMP environment. • Managed 35 staff during highly regulated blood collection process to ensure safety, quality, purity, potency, of the product.• Provided technical direction and supervision to the unionized operations workforce.• Performed immediate corrective action to correct any variables preventing goal attainment.

Washington, Dc, Us

• Developed and executed system and process audits to ensure that operational departments are operating within compliance and prepared for external Federal audits (FDA).• Team lead on performing root cause analysis investigations for deviations, monitored the implementation and effectiveness of corrective action plans.• Researched company procedures, Code of Federal Regulation, and AABB standards to write and present non-conforming product cases to the Material Review Board for evaluation and final disposition of suspect product.• Regional Quality Assurance liaison for hosting FDA auditors during annual inspection• Reviewed Equipment Validations, Qualifications, Advertising and Promotions, Labeling material, Batch Release records, inspect returned blood products for redistribution, customer concern coordinator.

Washington, Dc, Us

• Assisted Quality management in implementing and enhancing new and existing quality systems.• Assisted in design and implementation of a Regulatory Reporting QA Testing Plan covering Trade and Transaction Reporting, including designing, coding and deployment of QA tests.• Developed and conducted system audits to ensure product and process quality is maintained in all operational departments.• Collaborated with product specialists and others to effectively deliver solutions to customers.

Washington, Dc, Us

• Managed all precautionary and safety measures to control equipment operations and ensured periodic checks and corrections.• Verified all validation plans met the all Federal quality standards and requirements.• Reinforced and enhanced residual policies, controls and analytical approaches to support company’s equipment and risk management objectives.• Assisted in strategic cost saving measures by increasing efficiency.• Maintained databases, resource/reference materials, and a library of equipment document history and performance.

Project Management

Business Administration And Management, General

General Studies