Makaia Willoughby
Malvern
Summary
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
7
7
years of professional experience
Work History
Quality Compliance Associate
CBRE
06.2024 - Current
- Implement and manage an effective legal compliance program.
- Provide hands on training as required.
- Develop and review company policies.
- Advise management on the company’s compliance with laws and regulations through detailed reports.
- Create and manage effective action plans in response to audit discoveries and compliance violations.
- Regularly audit company procedures, practices and documents to identify possible weaknesses or risks.
- Assess company operations to determine compliance risk.
- Ensure all employees are educated in the latest regulations and processes.
- Resolve employee concerns about legal compliance.
- Audit Operations data is correct and audit ready (Maximo, Talent Coach, Summit).
- With support from the Operations Team, participate in planned and unplanned audits.
- Working with the Operations Team, complete and submit Significant Event Reports (SER).
Senior Specialist, Quality Compliance Training
Adare Pharma Solutions
05.2023 - 01.2024
- Serve as training administrator for LMS (Learning Management System): Veeva Vault
- Conduct cGMP training for all new hires at the Philadelphia site
- Create, schedule, and conduct cGMP training annually to ensure compliance with internal and regulatory training requirements.
- Collect, compile, and review training metrics.
- Support author of SOPs in revising SOPs and exams
- Manage curricula organization and structure to ensure employees are trained appropriately.
- Collaborate with department managers to oversee and administer the annual review of curricula
- Support departments that require on-the-job (OJT) training to manage the structure and documentation of such training as applicable
- Retention of training documentation
- Participate and support client and regulatory audits
Quality Assurance Auditor 1
Charles River Laboratories
05.2021 - 05.2023
- Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records and controls to ensure compliance with regulations and international standards.
- QA Scheduling and Coordinating.
- Report shipping
- Assure Charles River's compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
- Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
- Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.
- Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
- Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory Inspections.
- Participate in the development of corrective and preventative actions to respond to client visit and regulatory Inspection findings.
- Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
Associate Quality Assurance Auditor
Charles River Laboratories
07.2019 - 05.2021
- Communicate all identified compliance and quality risks to supervisor.
- Assist auditors with data audits to assess that the records are attributable, legible, contemporaneous, original, accurate and in compliance with regulations, international standards, SOPs, protocols/batch records and corporate policies and procedures.
- Assist auditors with the review of SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards and corporate policies and procedures.
- Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
- Assist auditors with preparation for sponsor site visits and the review of QA files; assure that QA audit files are retained.
- Assist auditors in identifying, documenting, reporting deviations from regulations, protocols/batch records, SOPs and specifications.
- Perform a preliminary review of protocols/batch records and reports to assure accuracy, completeness and compliance with regulations, international standards and company policies and procedures.
- Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records and controls to assure compliance with regulations and international standards.
- QA Scheduling and Coordinating.
- Report shipping
- Perform all other related duties as assigned.
Document Control Specialist II
Charles River Laboratories
04.2018 - 07.2019
- Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents. Assist in organizing QA records and archiving.
- Maintain historical files for SOPs and forms.
- Assure that site document management strategies and regulatory requirements for electronic documents are upheld.
- Enter, update and edit controlled documents and coordinate requirements for new documents with internal customers.
- Maintain the Master Schedule.
- Serve as a local system administrator for the QMS (Quality Management System) including responsibility for establishing user accounts and assigning roles and access privileges.
- Assist in QA auditors with QA record archiving and administrative support.
- Manage the daily flow and final release of controlled documents through the document management system.
- Serve as the local system administrator for the Document Management System known as Charles River Online SOP System (CROSS) including responsibility for establishing user accounts and assigning roles and access and privileges.
- Exhibit a thorough knowledge of the CROSS application and establish and maintain strong local administration support.
- Serve as the back-up system administrator for CROSS and QMS serving all Charles River operations which includes responsibilities for establishing user accounts, assigning roles and access and privileges.
- Perform all other related duties as assigned.
Education
Bachelor of Science - Business Administration & Health Care Administration
Gwynedd Mercy College
Philadelphia, PA05.2013
Skills
- Database management
- Teamwork and collaboration
- Regulations
- Attention to detail
- Multitasking Abilities
- Organizational skills
- Team collaboration
- Documentation skills
- Data entry
- Training and development
- Document review
- Data analysis
- Records review
- Auditing experience
- Records management
- Excellent communication
Accomplishments
- Achieved Client satisfaction by completing Report shipping with accuracy and efficiency.
Timeline
Quality Compliance Associate
CBRE
06.2024 - Current
Senior Specialist, Quality Compliance Training
Adare Pharma Solutions
05.2023 - 01.2024
Quality Assurance Auditor 1
Charles River Laboratories
05.2021 - 05.2023
Associate Quality Assurance Auditor
Charles River Laboratories
07.2019 - 05.2021
Document Control Specialist II
Charles River Laboratories
04.2018 - 07.2019
Bachelor of Science - Business Administration & Health Care Administration
Gwynedd Mercy College
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