Control Inspector Quality Manager
Resume:
CARMEN LAWSON
McDonough, Georgia 30252
****************@*****.***---770-***-****
Highly motivated manager with 25 years of experience monitoring, coaching, and developing medium to large groups of employees to achieve organizational goals. Proven track record includes the following:
Effective management of employee performance including appraisals, support, training, and discipline.
Development and maintenance of a safe work environment to meet all health and safety standards.
Planning and management of resources that consistently meet quality and cost goals.
Resolution of critical issues in a time-sensitive environment using excellent analytical skills.
RELEVANT EXPERIENCE
Quality Manager (2019-Present)
VERO-BIOTECH
Responsible for day-to-day management of in-house Manufacturing of the Vero cassette. Conducts all manufacturing operations in accordance with quality policies, regulatory guidance and commercial demands for products and services. Manages manufacturing technicians / operators in accordance with company and shop floor policies, including Regulatory and Safety requirements. Leads initiatives to control and reduce manufacturing cost and will champion continuous improvement activities, including building a Lean culture. Defines appropriate KPIs and develops visual dashboards that measure performance. Is responsible for building and sustaining a team that delivers against quality, financial and commercial expectations.
Manage manufacturing area in accordance with QMS and GMP guidance and regulations for both device and pharmaceutical manufacturing.
Establish and enforce shop floor controls ensuring shop floor is safe and clean.
Manage a build plan in support of service-level commitments.
Manages and delivers daily production schedule (runs Start of Day / End of Day Meetings).
Ensures each room is staffed properly (Headcount, Training, Leadership)
Reviews logbooks and batch records daily to ensure completeness and timely reviews.
Control inventory on the production floor; Manage compliance of material and labor with work orders and reconciles variances.
Investigate and report on any non-conformity including identifying and implementing appropriate corrective actions.
Recruit, train and retain top manufacturing talent. Includes a regular commitment to networking and maintaining a bench of direct labor candidates.
Creates individual development plans and provides regular performance feedback.
Scale manufacturing in support of commercial objectives and sustain manufacturing throughput of commercial and financial goals.
Provide resources to assist with pilot production and early stage design transfer activities.
Demonstrate deployment of Lean tools for Visual Management, Problem Solving and Value Stream Optimization.
Quality Control Inspector Lead (2018-2019)
VERO-BIOTECH
Work with production supervisor and leads to coordinate inspection priorities for 8 different processes. Ensure daily cleaning processes are performed and product is processed using Good Manufacturing processes and good documentation processes.
Perform line clearance to start production and end production
Complete sample request form to submit production samples to the Analytical lab
Participate in GEMBA walks to identify opportunities for improvement
Generate NCRs to address quality issues, including performing root cause analysis for investigation, reviewing and dispositioning
Use NetSuite ERP system to perform inventory transactions
Use Trello and Monday.com for tracking and completing action items
Conduct Batch Record Reviews
Conduct in-process inspections for eight different sub-assembly processes including Inspecting wires for good crimps and performing leak test.
Work with supply chain to conduct raw material weigh process
Train new employees
Use Quality management system QCBD (Quality Collaboration by Design.
Quality Control Inspector (2008 – 2018)
American Panel Co-operation
Daily identify and inspect products and materials for defects or deviations from specifications.
Monitor operations to ensure that they meet production standards and recommend adjustments to the assembly or production process. Inspect, test, or measure materials or products being produced.
Read blueprints and specifications
Monitor operations to ensure that they meet production standards
Recommend adjustments to the assembly or production process
Inspect, test, or measure materials or products being produced
Measure products with rulers, calipers, gauges, or micrometers
Accept or reject finished items
Remove all products and materials that fail to meet specifications
Discuss inspection results with those responsible for products
Production Supervisor (2002-2008)
CIBA Vision Corp. (Novartis Company)
Responsible for supervising a high-performance team of 40 employees in a manufacturing and assembly environment. Daily duties included: Assigning work, implementing policies and procedures and recommending improvements in production methods, equipment, operating procedures and working conditions.
Establish clear cut targets, priorities, cause/effects and deliverables
Hiring, training, and coaching of shift production staff to include company required annual performance reviews, recognition, counseling, and disciplining.
Achieved process improvement through action reviews, trend analysis, problem identification, and resolution.
Review and audit weekly Kronos time records and make necessary changes.
Suite Coordinator (2001-2002)
CIBA Vision Corp. (Novartis Company)
Coordinate and expedite the flow of work and materials within or between departments according to production schedule. Coordinate with department Supervisors to determine progress of work and completion dates, compiling reports on progress of work, inventory levels and production problems. Planning and ensuring material availability to support build schedules.
Interim in supervisor’s absence/assist with production needs
Draft performance evaluations, counsel sheets, lesson/development plans, and injury reports.
Mentor 4 highly trained technicians in leadership development and provide guidance to maximize production output.
Retrieve and analyze production metrics and formulate strategy to improve efficiency.
Production Technician (1999-2001)
CIBA Vision Corp. (Novartis Company)
Daily set up, maintain, and operate automated machinery to ensure the interminable and efficient running of production.
Perform machine set-ups, quality checks, operating and adjusting of equipment.
Perform preventative and corrective maintenance on highly automated machinery, troubleshoot machinery faults and train team members.
Maintained documents and records for ISO/FDA/GMP compliance.
Highly active participant in a high-performance team environment.
Awards & Acknowledgements
Excellent verbal and written communication skills
10+ years of Quality and/or Manufacturing experience with 5+ years of Supervisory experience
Committed to excellence and high standards
5S-Workplace Organization Training Course
Tap – Root Cause Analysis
International Organization for Standardization (ISO) Training Course
Occupational Safety and Health Administration (OSHA) Compliance Training
Management/Training the Trainer Workshops
Red Lined Standard Operating procedures
Performed Safety and Internal Audits
•On the Job Training for New Hires
EMPLOYMENT HISTORY
VERO-BIO TECH Quality Manager 2019-Present
VERO-BIO TECH Quality Manager 2019-Present
AMERICAN Panel Corp Quality Inspector 2008-2018
CIBA VISION Production Supervisor 1999-2008
EDUCATION
United Electronics Institute -Tampa, FL Associates Degree
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