Piano
MICHAELA MCKINNEY
Plymouth,United States
Summary
Results driven project manager with experience in medical laboratory science, adept at navigating complex regulatory environments. Proven ability to manage projects effectively while ensuring compliance with FDA regulations and international standards. Recognized for strong multitasking capabilities and the ability to thrive under pressure.
Expertise in project management and technical documentation related to MDR requirements positions as an ideal candidate for advancing the field of regulatory affairs and committed to continuous professional growth and contributing to organizational success.
Resourceful Project Manager with 2.5 years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions.
Overview
5
5
years of professional experience
1
1
Certification
Work History
QA Project Manager
Ranfac Corp
09.2022 - Current
- As a QA Project Manager at Ranfac Corp, I oversee quality assurance projects to ensure compliance with regulatory standards and internal policies
- This role involves collaborating with cross-functional teams to enhance product quality and streamline processes
- Write, improve, and maintain procedures to comply with all regulatory requirements
- Work and present Regulatory Strategy Plans
- Leading quality assurance initiatives to meet21CFR FDA, ISO13485, MOR, and MDSAP requirements
- Conducting internal audits and assessments to ensure adherence to international standards
- Host supplier/customer audits of Ranfac's QMS as lead auditee
- Assist customer requests with Regulatory or Quality documentation including but not limited to, drawings, technical documentation, lower level drawing specifications, REACH, ROHs, PFAS, BSE/TSE, CMR
- Training team members on quality standards and best practices to foster a quality-centric culture
- Lead and collaborate on continuous improvement projects for QMS
Medical Technologist
South Shore Hospital
06.2020 - 06.2024
- Performed Laboratory testing including but not limited to CBCs, Fluid Counts, coagulation testing
- Performed Quality Control, Preventive Maintenance, and Calibration of laboratory equipment
- Utilized medical technology and equipment to diagnose and treat medical conditions
Quality Assurance Coordinator II
Repligen Corporation
10.2021 - 07.2022
- Implementing corrective actions and preventive measures to address quality issues
- Developing and maintaining technical documentation in compliance with MOR regulations
- Ensured quality assurance processes were followed to ensure maximum product quality
- Managed QMS system to ensure proper and timely closure of Deviations, CAPAs, and NCRs
- Completed industry questionnaires per ISO9001 Involved in ISO9001 audits
Education
Medical Laboratory Science
UMass Dartmouth
05.2019
Skills
- Analytical Thinking Skills
- Quality Assurance
- Project Management
- Regulatory Compliance
- Technical Documentation
- Cross-Functional Collaboration
- Audit Assessments
- Project management
- Project planning
- Project planning and development
- Project scheduling
- Team collaboration
- Strategic planning
Certification
Regulatory Affairs Professional Society (RAPS) Member
BSI ISO 13485:2016 Auditor Certifications (Internal, External)
MLS (ASCP)
Accomplishments
Implemented a cloud-based employee training program, replacing cumbersome paper-based training with an easily accessible and streamlined system. This initiative significantly improved audit compliance by enabling rapid retrieval of training records, thereby preventing non-conformities (NCs).
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Interests
Horse Back Riding
Guitar
Languages
English
Native or Bilingual
Software
SAP
Sage 100
Enzyme
Document Center
Affiliations
- Regulatory Affairs Professional Society
Timeline
QA Project Manager
Ranfac Corp
09.2022 - Current
Quality Assurance Coordinator II
Repligen Corporation
10.2021 - 07.2022
Medical Technologist
South Shore Hospital
06.2020 - 06.2024
Medical Laboratory Science
UMass Dartmouth
Similar Profiles
Oralia ReyesOralia Reyes
Business Manager at Fair Trucking Corp/Famrey Trucking CorpBusiness Manager at Fair Trucking Corp/Famrey Trucking Corp
MANZI CrevisMANZI Crevis
Warehouse Laborer at HEXO Corp | HEXO CorpWarehouse Laborer at HEXO Corp | HEXO Corp
John CaseyJohn Casey
Senior Service Representative at Croker Fire Drill Corp. | Croker Fire Safety Corp. | Croker Fire & Life Safety InstituteSenior Service Representative at Croker Fire Drill Corp. | Croker Fire Safety Corp. | Croker Fire & Life Safety Institute
Ryan GarciaRyan Garcia
Sale and Marketing Consulting at Gypsum ConsultingSale and Marketing Consulting at Gypsum Consulting
JAMES SIMERSONJAMES SIMERSON
General Manager of Operations at F & L DoorsGeneral Manager of Operations at F & L Doors