Moises Hernandez
Experienced professional in Post Market Surveillance, Document control, NCR, MRBs CAPAs, Deviation
- Role
- Document Control Specialist at Watson-Marlow - North America
- Location
- Arlington, MA, US
- LinkedIn followers
- 500 followers
About Moises Hernandez
A very responsible yet highly motivated worker with a great deal of experience in manufacturing. As I have worked most of my career in the manufacturing area, makes me aware of keeping a high enthusiasm and identified with the companies\' goals. A true team worker, able to separate time to get involved into other projects which makes me a good asset in a cross functional environment.My experience includes: DOE, SPC, Quality Assurance, Metal Deformation, Lab Experience Trackwise complaint module FDA 21 CFR Part 820 FDA 21 CFR Part 803 ISO 13485 Risk Management analysis for medical devices Trend Analysis Root Cause Analysis Complaint investigation ECO review Legal Complaints
Experience
Document Control Specialist
Nov 2024 — Present
Managing document control processes to ensure compliance with GDP, FDA, ISO, and internal QMS requirements. Creating, revising, and maintaining controlled documents (SOPs, work instructions, forms) using standardized numbering, version control, and change management. Coordinating document review and approval workflows with SMEs and cross-functional stakeholders. Maintaining secure document repositories and ensure timely retrieval during audits and inspections. Review manufacturing Batch Records for accuracy, completeness, and GDP compliance prior to release. Support of internal and external audits by preparing documentation, retrieving records, and tracking corrective actions. Train employees on document control procedures and communicate procedural updates. Maintaining training records and collaborating with departments leads to managing the site training matrix and training compliance. Identified and implement continuous improvement opportunities within document control and QMS processes.
Education
Quincy College
Biotechnology
Western New England University
Master's degree, Engineering/Industrial Management
Universidad Autónoma de Santo Domingo
Industrial Engineering
Western New England University
Master Science, Engineering Management
Universidad Autónoma de Santo Domingo
BS, Industrial Engineering
Western New England University
Engineering/Industrial Management
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