Supply Chain Operations Manager
Resume:
ROBIN MONTANA
OPERATIONS MANAGER / BUSINESS ANALYST
CONTACT
**********@*****.***
linkedin.com/in/robinmontana
Greater Denver Metro Area
PROFILE
● People Manager; Project Resource Management, Human Resource Management
● Managed consultants supporting GxP clients; Project Management, GxP Engineers, Computer System Validation and GxP Computerized Systems
● Systems and process experience includes ERP Systems (SAP), MES
(Werum PAS X Manufacturing Execution System), iGMP (instant GMP), Change Control, Non-Conformance, Maximo, and Compliance Systems including Microsoft Suite programs
● Qualified by B.S. degree, Project Management, Document Management, Continuous Process Initiatives, Change Management and supplemental training in Six Sigma and Requirements Gathering Certification
● Client service oriented with strong communication, collaboration, and interpersonal skills
● Proven leadership ability and experience. Worked with Global cross-functional teams and SMEs from Information Systems, Supply Chain, Finance, Facilities & Engineering, Research & Development, Process Development, Quality, and GMP Manufacturing Operations
● Past performance reviews reveal my strong values for safety and integrity exemplified through my excellent organization, coordination, time management, and people motivational abilities SKILLS
● CGMP BIOPHARMA
● BUSINESS PROCESS
● COMPLIANCE
● SOP/CAPA/NC
● CHANGE MANAGEMENT
● MANAGEMENT
● LEADERSHIP
● TEAM BUILDING
● TRAINING DEVELOPMENT
● SUPPLY CHAIN
● PROJECT EXECUTION
● BUSINESS SYSTEMS
EXPERIENCE
cGMPnow LLC October 2020- December 2023
HUMAN RESOURCE MANAGER
Responsible for the overall coordination of all internal and external resource allocation management to ensure effective project execution and day-to-day operations. Transitioned to full time HR Manager
Managed the resource strategy and allocation
Align resource needs to support dynamically changing project phases
Negotiated allocation of resources across the company project profile
Authored and implemented numerous company policies
Managed and executed the employee lifecycle stages; Recruiting, Interviewing, Hiring, Onboarding, Employee Engagement, and separation
Performed administrative HR tasks; timesheet review, managed the HR database, training program, and training program
Developed professional performance training program
Responsible for company marketing and social media plan
Coached and supported up to 40 employees, including leadership team as an HR leader
Treehouse Biotech, January 2019 – May 2020
OPERATIONS MANAGER
Responsible for the day-to-day operations of Production, Sales & Marketing, Human Resources, AP, and Supply Chain
Implemented an MES system, and elevated the business to ISO and GMP standards
Drove the company to a successful GMP certification, Kosher certification, and Organic Certification
Authored SOPs for Supply Chain, QA, and MES system operations
Configured batch records, warehouse locations, vendors, and inventory in MES system
Manage GMP material supply, and chain of custody process for Finished Goods
Created and trained all personnel on Change Management, Risk Analysis, Non-conformance and Corrective Action Preventive Action program
Created a performance management program; goals, performance reviews, feedback platform, training and development, one-on-one guidelines, and leadership attribute development
Working towards ISO 9001 and ISO 17025 compliance
Vendor relations management
Provide HR guidance to Management and Staff. Created performance review program. Training development. Lead in the developed Mission, Values, and Goals
Authored and established policies and standards for AP, AR, purchasing, payroll, and HR functions
Responsible for limited liability insurance plans, Workers Compensation, Health insurance program, and compliance with unemployment regulations and filing
Configured OS and end user profiles to meet company standards
Troubleshoot basic IT issues as needed
Responsible for on-site security program
Developed HR and Compliance policies in response to COVID-19 pandemic
AstraZeneca, Americas, Global Factory Operations February 2018 - October 2018
GLOBAL ERP/MES INTEGRATION BUSINESS ANALYST
Deployed an integrated SAP/MES shop floor solution in the China Packaging facility. Developed Global standards for interface table characteristics and revised validation documentation for UAT, SAT, and other validation documentation.
Business needs identification, process mapping and stakeholder analysis in support of introducing new business systems to production lines
Analyze and assess business needs including continuous process improvement or improve or integrate MES/SAP with manufacturing and packaging processes
Proven experience of successfully deploying MES technology and complex integrated system in a regulated manufacturing environment.
Experience in mentoring, coaching, and developing others ABILITIES
● Critical thinking and problem
solving
● Manage multiple priorities and
multi-task with interruptions
● Professional with a calm
demeanor - able to diffuse
stressful situations
● Willing to travel up to 10%
● Effective working independently
● Effective and active learner
EDUCATION & TRAINING
Bachelor of Science Oregon State
University – Psychology, 1998
2023 - HR Summit
2023 - CBSA DE&I four part series
2023 - Thrive HR
2016 - Awarded IT Excellence Award
2016 - Information Systems Business
Analyst Boot Camp (28 IIBA CDU/28
PMI PDU)
2015 - Six Sigma Green Belt
2015 - Associates Certification in
Business Analysis
2015 - Business Data Modeling (25
CPE/ 21 PDU)
2015 - Agile Projects (27 CPE/22.5
PDU)
2014 - Gather and Document User
Requirements (CDU 28 / PDU 28)
Memberships & Associations
CBSA - Colorado BioScience Association
SHRM - Society for Human Resource
Members
BAHRA - Boulder area human resource
association
Rocky Mountain ISPE -
MESA Boulder County – Volunteer
STEMblazers - Volunteer
Special Olympics - Volunteer/Supporter
How I spend my time
Cooking & Baking
Gardening
Mountain Biking
Snow shoeing
Camping
Provide global support with up to 50% international travel supporting project and product development
Amgen, Inc. Colorado Operations. January 2000 – 2017 SUPPLY CHAIN MANAGER 2016-2017
Lead the re-start of the GMP and non-GMP shipping and receiving warehouse including reinstatement of vendor relations and services, hiring contingent workers, and Managing the training, safety, and inventory for GMP materials, consumables, and spare maintenance parts.
Managed end-to-end supply chain operations in preparation for the restart of a GMP production facility.
Work streams included: Central Inventory, GMP Material Procurement, GMP Material Receiving, Consumable inventory management, GMP cleaning services, and shipping.
Responsible for daily GMP Warehouse operations including, safety inspections, ensuring proper powered truck, material and personnel flows and functions.
Secondary responsibilities include planning and procurement of GMP raw materials within SAP.
BUSINESS SYSTEMS ANALYST - OPERATIONS INFORMATION SYSTEMS 2013-2016 Site Business Systems Analyst providing project and change management ownership for multiple business services/systems, applications, software upgrades/installations/decommissions including PI Data Historian, Electronic Lab Notebook, LIMS, and MES (Manufacturing Execution System).
System owner in ServiceNow for GMP applications supporting Manufacturing, Engineering, and Process Development.
Provide on-site global MES support to Amgen operations in the Netherlands, Singapore, and North America.
Daily responsibilities include interfacing between third party contractors, technical teams, and business owners to resolve system performance issues, and lead on-going system lifecycle and process improvements.
Responsible for leading requirements gathering sessions, identifying gaps, process state mapping, researching solutions, reporting and metric tracking, and delivering compliant, validated business systems.
IS Site Project Plan lead for Colorado site shutdown including data migrations, data archrivals and system decommissions. SPECIALIST OPERATIONS - SUPPLY CHAIN 2008-2013
Liaison between Supply Chain and Manufacturing Operations to ensure systems, processes, inventory remained aligned through business process analysis and continuous improvement efforts.
Site Business Process Owner (BPO) for MES.
SAP lead for process order execution and MES shop floor order management.
Managed revision of SAP master data and recipes to align process to new costing standards. Worked directly with site and global finance teams.
Change Manager for GMP systems including electronic batch records, master data, and IPC configuration changes.
Site BPO and PM for MES upgrades, test execution, document creation and revision, and hyper care support.
Business Process Formulation: Lead workshops to identify gaps cross-functionally and between plants.
Hiking
Family
Training Delivery: SAP trainer for Process Order Execution and Warehouse Operations. MES Training Program Owner.
System Owner for building management system controlled and Inspection equipment in Supply Chain.
Project Management: Business Process Optimization/Continuous Improvement projects and Lead for the implementation of new or refined business processes.
Quality Process Owner for Product and Raw Material Staging for ACO Site.
SPECIALIST OPERATIONS - MANUFACTURING 2005-2008
SAP Global Change Management-Security Role Mapping Analyst SAP Implementation Team (Temporary Assignment)
Provided Subject Matter Expert (SME) support in the areas of weigh/dispense, warehouse, and intermediate product dispensing.
Represented Colorado as the Business Process Lead for Werum PAS X North America implementation.
Supported the Global ERP (SAP) implementation in the areas of role mapping, manufacturing, plan to stock, and warehouse.
Primary contact to Security liaisons managing updates and changes to role design; provided program wide updates for security & role mapping activities.
OPERATIONS MANAGER - MANUFACTURING 2002-2005
Provided day-to-day supervision of the GMP warehouse, raw material dispensing, lab wash, and autoclave operations.
Managed 24/7 shift structure in support of commercial manufacturing.
Ensured orderly, complainant, safe and efficient daily operations of the production support areas.
Interfaced with Regulatory inspections
Developed, implemented, and supported plant initiatives and procedures to support GMP Production.
Provided site support for global system processes; label control, inventory control, SAP validation, and training.
PROJECT COORDINATOR – ENGINEERING 2000-2002
Maintained project budgets and Master Plans for Longmont land acquisition. Authored Master Agreements with contractors. Reallocated committed funding as needed. Processed and tracked all proposals and invoices. Attended City of Longmont vested rights and application review meetings.
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