Maria Shoemaker Email & Phone Number
Senior Consultant, QA and Regulatory Compliance @ Multiple Clients or Companies
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Maria Shoemaker Location
- Bolton, MA, US
Maria Shoemaker Work
- Senior Consultant, QA and Regulatory Compliance @ (March 2025 - Present)
- Director, Quality Systems @ (January 2023 - March 2025)
- Senior Consultant and Corporate Auditor @ (February 2022 - January 2023)
- Sr. Consultant-Quality Assurance and Regulatory Compliance @ (February 2022 - January 2023)
- Sr. Director Quality Assurance and Head of Quality @ (October 2020 - October 2021)
- Sr. Consultant, Quality Assurance @ ArQule Pharmaceuticals Inc./Merck (April 2019 - October 2020)
- Consultant @ 3DBio Inc. (August 2017 - September 2020)
- Quality Assurance and Regulatory Compliance Consultant @ Biomedical Resource Consultants, Inc (April 2016 - August 2017)
- Consultant - Complya Consulting @ (October 2016 - June 2017)
- Consultant @ (April 2016 - September 2016)
- Global Director Regulatory Compliance @ (February 2014 - December 2015)
- Global Director of Quality and Regulatory Affairs-Nypro Healthcare Global Business Unit @ (February 2010 - July 2013)
- Global Director of QA and RA @ (February 2010 - July 2013)
- Senior Quality Manager @ (April 2001 - February 2010)
- Manager Quality and Global Design Assurance @
- Senior Auditor and Quality Engineer @ (April 2001 - April 2002)
- Senior Quality Assurance Specialist @ VI Technologies (March 2000 - March 2001)
- QC Supervisor @ (March 1996 - March 2000)
Maria Shoemaker Education
- Boston University
Masters in Science (Biology/Biochemistry)
1987-1990 - Suffolk University
BA (President -Beta, Beta, Beta (Biology Honor Society-Suffolk University Biology Dept.))
1982-1986
Maria Shoemaker Skills
- Injection Molding
- FDA GMP
- Lean Manufacturing
- Quality Assurance
- FMEA
- R&d
- ISO 13485
- Compliance
- Aseptic Processing
- Project Management
- Supplier Quality
- CE marking
- Regulatory
- Regulatory Affairs
- Computer System Validation
- Minitab
- Regulatory Requirements
- Computer System
- SPC
- Sop
- Cross Functional Team
- Quality Management
- Root Cause Analysis
- Design of Experiments
- Customer Service
- Regulatory Compliance
- Continuous Improvement
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Greek
- Supplier Evaluation
- Quality Auditing
- FDA
- Quality System
- ISO
- CQA
- Validation
- Iso 9000
- GxP
- Complaint Management
- ISO 14971
- DMAIC
- Medical Devices
- CAPA
- Manufacturing
- Design Control
- Change Control
- 21 CFR
- Design Assurance
- Business Development
- Quality Control
- Management Review
- GMP
- Corrective and Preventive Action Capa
- Corrective and Preventive Action
- u.s. Food and Drug Administration
Maria Shoemaker Summary
- Maria Shoemaker, based in Bolton, MA, US, is currently a Senior Consultant, QA and Regulatory Compliance at Self-employed. Maria Shoemaker brings experience from previous roles at Replimune, Thermo Fisher Scientific, ComplianceLogix and TScan Therapeutics. Maria Shoemaker holds a 1987 - 1990 Masters in Science in Biology/Biochemistry @ Boston University. With a robust skill set that includes Injection Molding, FDA GMP, Lean Manufacturing, Quality Assurance, FMEA and more. Maria Shoemaker has 1 emails and 2 mobile phone numbers on RocketReach.
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