Genesis Martinez
Senir Specialist Quality Assurance
Luneburg,MA
Summary
Forward-thinking Senior Specialist equipped with advanced operational and technical knowledge of Quality Assurance and Quality Control. Proven team leader and problem-solver competent in navigating complex situations. Manages assignments, schedules and projects with organized and detail-oriented mindset.
Overview
8
8
years of professional experience
1
1
year of post-secondary education
2
2
Languages
Work History
Senior Specialist- Quality Assurance
Bristol Myers Squibb
01.2023 - Current
- Maintained knowledge of industry best practices and evolving technologies, staying ahead of emerging quality assurance trends.
- Quality support of quality control laboratories, technical services programs and equipment maintenance activities.
- Review and approval of change controls, exception reporting, investigations, corrections and risk assessments associated with all areas of manufacturing process including Quality control related activities.
- Review and approval of validation protocols and reports associated with new products, analytical methods, equipment and materials.
- Team Member of audit response team.
- QA representation in cross-functional activities and projects.
- Knowledge of electronic systems such as SM LIMS, SAP, Infinity (Veeva Vault), Maximo and DocMan.
Team Lead
Bristol Myers Squibb
7 2022 - 12.2022
- Supported department leadership in implementing new policies, procedures and controls
- Established open and professional relationships with team members to achieve quick resolutions for various issues
- Identified areas in need of critical improvement and implemented strategies to achieve targets
- Evaluated employee skills and knowledge regularly, training and mentoring individuals with lagging skills
- Coached team members in techniques necessary to complete job tasks
- Root Cause Lead investigator
- Successful Trend Investigations with CAPA Implementations and cross functional support
- Oversees and supports various ongoing projects within the Sample Management Team.
- Communicated KPIs outlined in annual plan to inform employees of expectations and deliverables.
- Conducted regular reviews of operations and identified areas for improvement.
Quality Shared Services Specialist
Bristol Myers Squibb
06.2021 - 07.2022
- Subject Matter Expert during audits for Regulatory Retains
- Subject Matter Expert for Maximo and Asset Management
- Performs and troubleshoots routine and advanced processing and data review of raw materials, in-process, batch release, and stability samples of Bulk Drug Substance
- Training of junior analysts, in various test methods and QSS process including but not limited to Quality Control Door to floor training activities
- Lab acting lead overseeing day to day execution
- Manage team's documentation and ensure timely completion and review of paper and electronic documentation within Quality Control
- CAPA Support activities and timeline adherence
- Coordinates and monitors sample receipt and shipping activities across department and sites
- Weekly interaction with contract testing laboratories to forecast and monitor upcoming and ongoing work
- Oversee and provides guidance to junior analyst
- Process Improvement activities such as P1 value capture project
- Subject Matter Expert for Sample Management Infinity Deviation.
Sample Associate
Bristol Myers Squibb
01.2016 - 06.2021
- Lean Labs SME for scheduling and time management
- Complete area / equipment preventive maintenance per applicable procedures
- Implemented test method for various molecules stability freezing process
- Identify, Write, and revise SOPs, work instructions and various documents for managerial review and approval
- Audit readiness support
- CAPA support activities
- Perform receipt of raw materials, in-process, non-routine, release, and stability of the Bulk Drug Substance (BDS) in a cGMP environment for both commercial and clinical products
- Perform sample management including sample tracking, aliquot preparation and sample distribution for stability and stability enrollment
- Communicate issues with sample processing to area management
- Provide direct support to lab personnel to troubleshoot sample management issues
- Order, inventory and reconcile critical reagents/ testing material
- Prepare samples to be shipped to 2nd and 3rd parties (External Labs)
- Receive and process shipments/samples from 2nd and 3rd parties
- Enter QC Data and COA's to pertinent systems
- Lot disposition activities including, entering data, reviewing and authorization of samples
- Asset Management through Maximo, SME for the Sample management Lab.
Bioprocess Associate
Bristol Myers Squibb
01.2016 - 06.2018
- Scheduling and coordinating work order activities
- Implemented processes for business-critical alarms for assets
- Operate process equipment; chromatography columns skids, UF/DF skids, packing skids, glass washers, Buffer production equipment and membrane operations
- Bulk Drug Substance Fill / Recapping
- Perform routine manufacturing process using PAS (Process Automation System); Syncade, Delta V and OSI/PI historian
- CIP/SIP of process equipment
- Training junior operators
- Helped with the development and revision of SOPs
- Integrity Filter testing.
Education
Associate of Science - Biotechnology
Mount Wachusett Community College
Gardner, MA 01.2021 - 01.2022
Skills
Decision Making
CMS- Maximo
CMS- Infinity/Veeva
CMS- Sample Manager LIMS
Aseptic Techniques
Project Management
Scheduling
Microsoft Office Proficient
Spotfire KPI Tool
Root Cause Analysis
Process Improvement
Interpersonal Communication
Written Communication
Documentation Management
Timeline
Senior Specialist- Quality Assurance
Bristol Myers Squibb
01.2023 - Current
Quality Shared Services Specialist
Bristol Myers Squibb
06.2021 - 07.2022
Associate of Science - Biotechnology
Mount Wachusett Community College
01.2021 - 01.2022
Sample Associate
Bristol Myers Squibb
01.2016 - 06.2021
Bioprocess Associate
Bristol Myers Squibb
01.2016 - 06.2018
Team Lead
Bristol Myers Squibb
7 2022 - 12.2022
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