Teresa Vivas
Sanford,NC
Summary
Results-driven Operations Manager with extensive experience at Merck Durham Plant, recognized for enhancing safety culture and ensuring regulatory compliance. Proficient in SAP, with a strong focus on team development and leadership. Achievements include significant operational efficiency improvements and comprehensive team training initiatives that underscore a robust technical skill set and leadership capabilities. Committed to driving continuous improvement and fostering a collaborative work environment.
Overview
17
17
years of professional experience
Work History
Operations Manager
Merck
Durham, NC
08.2020 - Current
- Foster strong safety culture for team through coaching and actions
- Support the department’s safety initiatives including walkthroughs and proactive identification of potential hazards
- Participate in safety/regulatory audits
- Batch Record Review of all area processes and Review eLogs
- Lead and support daily (Tier) meetings to facilitate flow of information
- Escalate issues as needed to ensure the right support/awareness is given as they arise
- Regularly help the team troubleshoot issues to minimize downtime and maintain product quality
- Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team
- Provide clear consistent communication from shift to shift
- Provide a leadership presence on the manufacturing floor
- Provide leadership to the team as needed based on the team’s capabilities and maturity
- Manage team staffing and overtime to support customer demand to meet budget targets
- Coordinate and supervise daily activities, ensure shift objectives are achieved
- Develop team members and provide coaching/feedback on career path
- Utilize SAP, Delta-V, and MES systems to perform daily duties
Lead Technician
Merck
Durham, NC
04.2019 - 08.2020
- Assign roles to team members and ensure training is completed
- Assure teamwork is prioritized and schedule tasks according to schedule
- Batch Record Review of all processes and Review Logbooks
- Facilitate Team Handoff, Lead to Lead Handoff, and Coach backup
- Manage a sterile component Kanban and SAP storage bins
- Execute all duties in a manner consistent with cGMP, safety, environmental, human resources, and FDA policies and procedures
- Utilize SAP, Delta-V, and MES systems to perform daily duties
- Serve as department SAP subject matter expert and personnel trainer
- Support the department’s safety initiatives including walkthroughs and proactive identification of potential hazards
- Train team members on equipment and processes (i.e., Autoclaves, Equipment Washers, Stopper Processors, portable tank processing, CIP skids, testing filters, and assembling components) in accordance with Standard Operating Procedures
Sr. Production Technician
Merck
Durham, NC
05.2010 - 04.2019
- Operates equipment and processes (i.e., Autoclaves, Equipment Washers, Stopper Processors, portable tank processing, CIP skids, testing filters, and assembling components) in accordance with Standard Operating Procedures
- Executes all duties in a manner consistent with cGMP, safety, environmental, human resources, and FDA policies and procedures
- Utilizes SAP, Delta-V, and MES systems to perform daily duties
- Serves as department SAP subject matter expert and personnel trainer
- Works in a team environment to accomplish departmental goals
- Supports the department’s safety initiatives including walkthroughs and proactive identification of potential hazards
Sr. Glass Wash/ Solution Technician
Diosynth Biotechnology
Morrisville, NC
02.2008 - 05.2010
- Responsible for manufacturing support processes including glass wash operations, autoclaving, manual cleaning, and water sampling
- Performed changeovers, validations, and re-qualifications of equipment and processes
- Reviewed logbooks and data for accuracy
- Authored and revised SOPs and GMP documents
Education
High School Equivalency - Bio-work: Process Technician Training, Keyboarding and Intro to computers certificate
Central Carolina Community College
Sanford, NCSkills
- Team Training
- Operations Leadership
- Proficient in Spanish
- Conducting Performance Evaluations
- Team Development
- Proficient in SAP
- Inventory Management
Timeline
Operations Manager
Merck
08.2020 - Current
Lead Technician
Merck
04.2019 - 08.2020
Sr. Production Technician
Merck
05.2010 - 04.2019
Sr. Glass Wash/ Solution Technician
Diosynth Biotechnology
02.2008 - 05.2010
High School Equivalency - Bio-work: Process Technician Training, Keyboarding and Intro to computers certificate
Central Carolina Community College
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