Summary
Overview
Work History
Education
Skills
Timeline

Mishelle Richards

Rosharon,TX

Summary

Detail-oriented professional with extensive hands-on experience in manufacturing, quality control, and regulatory compliance within the biotechnology sector. Proven expertise in overseeing quality control activities including sample intake, testing, and release of GMP-manufactured products. Demonstrated commitment to maintaining sample integrity and ensuring adherence to GMP and GDP standards. Eager to advance to a challenging project management role with a reputable organization to drive further success in the biotechnology field.

Overview

18
18
years of professional experience

Work History

Quality Control Coordinator II

Fujifilm Diosyth Biotechnologies
03.2021 - Current
  • Support QC Managers to align in-process, FIO and outsource testing for client batches
  • Managed 15 projects, develop, and manage timelines, identify, and respond to critical path barriers
  • Implementing and managing QC operation activities supporting sample intake, testing, stability testing and release of GMP-manufactured products
  • Established and tracked quality department goals and objectives.
  • Manage Change Controls and Deviations
  • Participate in FDA and Client Audits and act as a SME for QC.
  • Improved communication between departments by facilitating regular meetings focused on addressing quality concerns.
  • Trained new hires on quality control protocols and best practices, fostering a culture of continuous improvement.
  • Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
  • Provided detailed project status updates to stakeholders and executive management.
  • Negotiated and managed third-party contracts related to project deliverables.
  • Completed projects within tight deadlines, coordinating team efforts and prioritizing tasks effectively.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.

Billing Specialist-Carved Out Team

United Healthcare
10.2016 - 03.2021
  • Collaborated with Internal Audit team and auditees to develop and execute corrective/preventive actions in a timely and efficient manner
  • Assisted colleagues in resolving complex billing issues, promoting teamwork and knowledge sharing within the department.
  • Improved customer satisfaction with prompt and clear communication regarding their billing inquiries.
  • Responded to customer concerns and questions on daily basis.
  • Oversaw 5 dedicated client accounts and produced 82% increase in client satisfaction
  • Resolved productivity and compatibility issues before deployment of multiple systems
  • Managed quality assurance program including on site evaluations, internal audits and customer surveys.
  • Identified, researched, and resolved billing variances to maintain system accuracy and currency.
  • Collaborated with customers to resolve disputes.
  • Achieved departmental goals by developing and executing strategic plans and performance metrics.
  • Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.

Billing Office Coordinator

TEXAS TENDER CARE HOME
05.2006 - 08.2016
  • Correctly coded and billed Medicare, Medicaid and HMO claims for Home Health Agency
  • Increased company profits by reducing rejected claims
  • Verified eligibility and claims status with multiple insurance agencies
  • Attentively filed and followed up on third party claims
  • Assigned appropriate medical codes with a 90 percent accuracy rate
  • In-serviced staff on HIPAA compliance annually
  • Conducted regular reviews of office procedures, identifying and implementing improvements for operational excellence.
  • Maintained accurate financial records by reconciling accounts payable/receivable transactions regularly to ensure balanced budgets.
  • Handled sensitive information with discretion, maintaining confidentiality of company documents and personnel records.
  • Coordinated office events and meetings, ensuring timely execution and optimal scheduling for all participants.
  • Implemented comprehensive training program for new hires, improving their integration into team and productivity.
  • Ensured timely completion of projects by monitoring progress and facilitating collaboration among team members.

Education

Associate of Science - General Studies

Houston Community College, Houston, Tx
02.2025

Skills

  • Project management
  • Microsoft Office
  • Master Control
  • TrackWise
  • Change Control
  • Sampling Plans
  • Effective Multitasking
  • Specification Review
  • Billing
  • Quality Metrics

Timeline

Quality Control Coordinator II - Fujifilm Diosyth Biotechnologies
03.2021 - Current
Billing Specialist-Carved Out Team - United Healthcare
10.2016 - 03.2021
Billing Office Coordinator - TEXAS TENDER CARE HOME
05.2006 - 08.2016
Houston Community College - Associate of Science, General Studies
Mishelle Richards