Maria Upia Torres
Perth Amboy,NJ
Summary
Determined Quality Assurance Specialist with dedication to quality and accuracy. Demonstrated leadership abilities in team management, development, and motivation for achieving shared goals. Committed to continually enhancing process efficiency to boost productivity while optimizing available resources. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist II
Pace Life Sciences formally Curia New Jersey, LLC
07.2021 - Current
- Ensure strict adherence to quality standards, meticulously reviewing and approving all quality-related records to maintain integrity of final analysis reports in compliance with regulatory and company guidelines
- Oversee tracking and release of Laboratory Tracking Numbers (LTNs) by ensuring accuracy, completeness, and compliance of all documents with regulatory standards, company policies, and industry best practices
- Manage and monitor daily operations of a team of four employees
- Develop team members, promoted a culture of continuous improvement, fostered teamwork, and upheld operational excellence
- Monitor operations personnel for adherence to standard operating procedures (SOPs)
- Author and revise Standard Operating Procedures (SOPs)
- Review and approve client protocols, test methods, standard operating procedures, and other documents within the electronic Document Management system
- Conduct comprehensive reviews of data for various departments, including Raw Materials, Microbiology, Medical Device, Packaging, Container Qualifications, and Container Closure Integrity
- Approve Certificates and Reports of Analysis
- Conduct regular facility walkthrough to ensure area compliance
- Review and approve investigations for deviations, out-of-specification (OOS), Corrective and Preventive Actions (CAPAs) and equipment excursions
- Conduct internal audits
- Lead external, and subcontractor audits
- Facilitate acquisition and comprehensive examination of documentation in preparation for audits conducted by regulatory authorities such as FDA and EU
- Thoroughly and promptly fulfill client questionnaires
- Conduct candidate interviews for Quality-specific positions
- Held Power of Attorney for DEA Form 222
- Serve as a backup for Site Environmental, Health, and Safety (EHS) personnel, evaluating hazard risk assessments, and ensuring compliance with EHS expectations and safety guidelines while distributing corporate data throughout the site
- Generated reporting of Quality Department KPI to management for monthly and quarterly review
- Presented in Quality Management Review - audits observations / recommendation and Quality KPI
Quality Assurance Specialist I
Curia New Jersey, LLC formally AMRI
03.2021 - 07.2021
- Maintained the company's IQ, OQ, PQ, PV and PM program for all Laboratory measurement and test equipment
- Reviewed and approved client protocols, Test methods and Standard Operating Procedures
- In electronic Document Management system, as applicable
- Uploaded Audit trails systematically from the following instruments: AA, UV-VIS, IR, and DSC)
- Reviewed data for the following departments: Raw Materials, Microbiology, Medical Device, Packaging, Container Qualifications and Container Closure Integrity
- Coordinated and responded to client quality questionnaires as necessary
- Ensured the Pest Control technician maintains a valid pest control license and adheres to our current training protocols
- Managed the preparation, issuance, and review of pest control documentation and reports
- Verified the compliance of pesticide usage with our established procedures
- Contributed to the development and facilitation of training programs for new employees
- Power of Attorney for DEA Form 222
- Maintained controlled substance documentation while ensuring compliance
- Assisted with document issuance activities (Report issuance, Issuance of Laboratory Data Sheet; etc.)
Quality Assurance Associate
Curia New Jersey, LLC formally AMRI
05.2017 - 05.2021
- Responsible for review of data and generation of client specific Report of Analysis and Certificate of Analysis
- Reviewed IQ/OQ/PQ/Calibration for instrumentation
- Completed laboratory walkthrough to make sure labs are in compliance
- Assisted with FDA audit by being part of back room and retrieving requested documentation.
Education
Bachelors of Science - Biochemistry
Georgian Court University
Lakewood, NJ05.2015
Skills
- Bilingual: Spanish
- Microsoft Office
- Microsoft 365
- Stratas - Sparta Systems
- Trackwise Digital - DMS and EQMS
- Empower Software 3 - LCs
- ChemStation - LCs
- Agilent Technologies - ICP-MS, AA, and UV-Vis
- VelocityEHS
- Good Manufacturing Practice (GMP)
- Team Collaboration
- Regulatory Compliance
- Team Leadership
- Quality Management Systems
- Internal and External Audits
- Quality System Implementation
Certification
- ISO 9001: 2015 Certified Lead Auditor Training
- Mahoney Institute - Team Leaders Training
Timeline
Quality Assurance Specialist II
Pace Life Sciences formally Curia New Jersey, LLC
07.2021 - Current
Quality Assurance Specialist I
Curia New Jersey, LLC formally AMRI
03.2021 - 07.2021
Quality Assurance Associate
Curia New Jersey, LLC formally AMRI
05.2017 - 05.2021
Bachelors of Science - Biochemistry
Georgian Court University
- ISO 9001: 2015 Certified Lead Auditor Training
- Mahoney Institute - Team Leaders Training
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