Professional Quality Assurance Technician, and Training Specialist with over 10 years experience in the Biotech and Pharma Industry. I benefit with an extensive background in CAPA, Complaints, Auditing, Supply Chain, Training Facilitation, Curriculum Development, Safety and Compliance, and Document Control and Change Management to name a few. I have been highly involved in Supply Chain aspects of Biotech, including cold chain, logistics, planning, scheduling, investigation, and auditing

With a proven track record of Continuous Improvement by utilizing business excellence skills, reducing costs, and seeking out efficiencies in every job process I perform, I focus on reducing risk and increasing compliance. I excel in communication and am proficient in Learning Management System and SharePoint.

Accomplishments

Supervision – managed a staff of up to 230 employees in both retail, military, project management and restaurant environments

Author –wrote multiple internal Quality System Documents/Technical Writing and training presentations

Quality System- managed the document center and change control process for AbbVie Specialty Pharmacy Quality System in compliance with all cGMP, ISO 9001 and ISO 13485 standards for device and combination drug/device requirements including collaboration and training creation with Pharmacovigilance department including usage of the Document Management System (DMS) and Sharepoint

Training/Facilitation– successfully managed the Learning Management System (LMS) including development and review of curriculum, logistical coordination of training events globally, record management, vendor contract and Statements of Work negotiation, creation of training presentations and facilitation of classes.

Technical – successfully manage SharePoint and Isotrain as Subject Matter Expert administrator including system audit and reporting in a specialty pharmacy environment

Quality –maintained compliance under departmental, Corporate, Regulatory Affairs, Employee Health and Safety, Drug Enforcement Agency (DEA), Department of Transportation (DOT), Pharmacy Board and Food and Drug Administration guidelines (FDA), including ACHC Accreditation. Enforced compliance with ISO 9001 and ISO 13485/GMP 21 CFR 820 and ISO 14971 standards for device and combination drug/device requirements.

Supply Chain-compliantly executed Cold Chain Management, Corrective Action/Preventive Action (CAPA), Complaint handling, Auditing and Controlled Drug administration including Import /Export compliance.

Planning- managed and assisted with the planning of Active Pharmaceutical Ingredients (API) inventory supply for Hospital Products Division Planning and Global Pharmaceutical Operations (GPO) Biologics commodity replenishment.

Skills:

Change Management

Project Management

DMS/eCR

Auditing

Continuous Improvement

Problem Solving/Resolution

Impact Assessment

Risk Assessment

Regulatory Inspection Readiness

Disaster Recovery

Quality Document Management

Class A

Lean Six Sigma tools

Second language: Spanish

Facility and Employee Safety

Succession Planning

Inventory Management

Aseptic Technique

Training Specialist II

Catalent Pharma Solutions-Woodstock, IL July 10, 2017 – September 15, 2017

Conducted needs assessments with department management and designed curriculum and instruction.

Facilitated group and individual training sessions, including the scheduling, training, materials/media development, presentation and record keeping.

Provided Continuous Improvement of the training program.

Provided guidance to and ensure compliance in GMP training practices and documentation.

Facilitated sessions to groups or individuals in the areas of Regulatory processes such as SOPs, cGMP, Occupational Health and Safety and leadership, Onboarding and New Employee Orientation.

Created and facilitated interpersonal development training.

Interfaced with all departments to provide support and oversight of training compliance.

Participated in internal audit, inspection preparation and change control.

Taught label verification and defect recognition.

Conducted Training System assessment and developed gap analysis plan through Value Stream Mapping.

Pharmacy Licensing and Compliance Analyst

AbbVie -North Chicago, IL April 4, 2016-January 13, 2017

Successfully maintained Pharmacy and Controlled Drug compliance for all fifty states by tracking all licenses, including renewal application submission, ensuring pharmacy compliance against all state laws (Pharmacy RA).

Maintained all pharmacist, nurse and pharmacy technician licenses and certifications for compliance with applicable state requirements for over three hundred employees in a Call Center environment.

Successfully maintained security clearance and building access as required by Pharmacy Laws.

Implemented alarm report monitoring assuring compliance with state law

Organized and restructured all electronic and hard copy files for ease of use and location to allow the pharmacy to be inspection ready at all times.

Conducted label verification aspects for pharmacy prescription requirements.

Coordinated and managed record retention for pertinent pharmacy documents including compliance with Centers for Medicare and Medicaid activity.

QA Training Specialist

AbbVie-North Chicago, IL Nov 11, 2013 – April 4, 2016

Compliantly managed the Pharmacy Document Center and Change Control for Quality System Documents

Single handedly completed a project for redevelopment and redesign for the QA site in SharePoint as a Continuous Improvement project.

Developed and implemented trainer qualification, training review change control and training effectiveness based on Gap Analysis.

Developed metric reporting for Change Requests, Document (Doc) Center, and Continuous Improvement activity.

Introduced Curriculum development and deployed the updates in the Learning Management System as part of a second Continuous Improvement project utilizing Root Cause Analysis tools to resolve various gaps.

Trained and developed SMEs, Approvers and Quality Assurance (QA) reviewers with all aspects of our internal Change Control Processes and systems, in a Call Center environment of over three hundred employees as per 21 CFR 820.25 and 211.25

Effectively and timely performed receipt, review and processing of Complaint investigations for Sales Reps and doctor’s offices with regards to Pharmacy and Employee performance and determined proper resolution.

Led and participated in front and back room activities for Audits and response including remediation submission, retrieving requested records and recording of all events during the audit.

Successfully maintained the Quality System in audit readiness status by frequently performing self audits against regulations and Quality System requirements.

Assisted with Government compliance and training programs for our internal Office of Ethics and Compliance enhancing my skills and understanding of HIPAA and other related payer laws.

Led security initiatives and performed back up duties for front desk reception in order to maintain Illinois Pharmacy Law requirements.

Interacted with all applicable regulatory boards and product safety departments including streamlining, collaborating with and developing product complaint tracking methodology for Pharmacovigilance (PV) as part of my Continuous Improvement duties.

Streamlined training system effectiveness by implementing Curricula processes in the Learning Management System for Pharmacy Solutions, creating efficiencies with Onboarding and Off-boarding of employees, and accuracy of training curriculum for specific job functions.

Quality Assurance Training Coordinator

AbbVie-North Chicago, IL Dec 10, 2012 – Nov 11, 2013

Implemented annual document review and streamlined all operations Quality System documentation into a better to use format for Call Center employees, including training facilitation and evaluation.

Successfully led miscellaneous projects and implemented Business Excellence improvements as necessitated by audit findings.

Lead Continuous Improvement as team lead involving IT, Call Center Operations, SharePoint Database, the Patient Processing System and Employee Safety, including training and support to all updates performed.

Compliantly performed impact and gap analysis for all documentation change requests.

Precisely conducted data analysis and metric reporting on Change Request and Doc Center activity for the Call Center.

Implemented Taken Past due training investigations and exception reporting for the Pharmacy training program as a Continuous Improvement project.

Implemented Deviation process for Pharmacy Operations based on GAP Analysis and performed CAPA investigations including resolution planning and effectivity checks.

Compliantly managed and maintained training curriculum for Call Center operations including New Hire On-boarding and Off-boarding, defect recognition and label verification.

Implemented Employee Health and Safety programs according to OSHA and AbbVie standards.

Quality and Regulatory Training Coordinator

Abbott Laboratories-North Chicago, IL June 2010 – Dec 7, 2012

Successfully managed the Isotrain learning management system.

Coordinated scheduling, training material duplication and ordering.

Coordinated logistics for numerous domestic and international CAPA and Complaint classes for the Quality and Regulatory department.

Created and updated developmental training in the Abbott Training Registration System (ATRS) including yearly training forecast and schedule update.

Redlined and updated numerous Operating Procedures and training courses in order to align with Abbott’s Quality System.

Conducted metric reporting for CAPA and Complaint training, monthly help desk reporting and financial reporting for classes conducted, including coordination of financial chargeback.

Coordinated and assisted in the Production of WEBEX training for global partners at international sites.

Managed contract negotiation for outside vendors including account tracking and payment for professional development courses worldwide.

As per departmental policy, evaluated and qualified Professional and Master Trainers for courses facilitation globally.

Continuous Improvement project, in collaboration with FedEx Office-designed, tested and implemented an online ordering software application for creating efficiencies in product ordering and duplication and allow for ordering directly from all global sites, increasing effectivity, saving shipping costs and creating accurate duplication of all files needed for affiliates worldwide.

Distribution Quality Assurance

Abbott Laboratories-North Chicago, IL May 2008 – June 2010

Performed product holds, package withdrawal, and rework investigations using Order Processing System (OPS).

Conducted CAPA investigations in Global Quality Management System (GQMS) as an Initiator/Evaluator, Investigator and Resolution Planner, up to and including implementation of proper corrections and corrective actions as well as effectivity checks as per 21 CFR 820.100

Conducted product complaint receipt, review and investigations as in Initiator/Evaluator and Investigator using the Product Complaint Analysis (PCA) website for finished product for customers and patients in accordance with 21 CFR Part 211.198 and 21 CFR 820.198.

Completed release of FDA and United States Department of Agriculture (USDA) importation issues.

Worked with Abbott Package Engineering with the study of transportation routes affecting Cold Chain products and packaging qualifications.

Monitored temperatures for compliance and tracked temperature monitoring devices and assured calibration testing was accurate and on time.

Audited Quality Systems including inventory, Controlled Drugs, Controlled Substance Transfer Records (CSTR) documentation/222 Forms and temperature logs for the Chicago Distribution Center.

Utilizing Value Stream Mapping, in collaboration with Abbott IT, created a network shared access drive for utilization by the team for remote access to integral systems for off hour use and ability to work remotely

Created a Disaster Recovery plan for QA as well as remotely storing all materials needed for performing QA tasks and obtaining lap top PCs for use by the team.

Conducted label verification for all incoming finished goods from manufacturing.

Created automated spreadsheet for aiding in the Controlled Drug bi annual inventory compliance reporting.

Successfully updated all SOPs and recreated new electronic forms for use by the QA team vs utilization of paper forms, resulting in cost savings and efficiencies including adherence to compliance based on electronic record keeping procedures.

Supply Chain Training Coordinator

Abbott Laboratories-North Chicago, IL June 2004 – May 2008

Actively and successfully managed training compliance for multiple departments under Global Supply using Active Learner and Isotrain learning management systems.

Created, implemented, maintained and updated job functional curricula.

Created and facilitated instructor led training for specialized job requirements.

Interacted with all levels of management for training compliance, curriculum approval and metric reporting.

Facilitated Continuous Improvement training for Global Supply Chain employees.

Conducted system migration from Active Learner AHD to Active Learner Specialty Products Division (SPD) and then consolidate the data into Isotrain.

Performed Class A introduction for New Employee Orientation of Supply Chain staff.

Successfully maintained audit preparedness.

Coordinated Flex training for the Chicago Distribution Center to help prevent personal injury and optimize departmental cost savings due to time off related personal injury.

Made recommendation to Abbott to open the recycling to all Abbott personnel who did not have recycling in their communities. Abbott reviewed and implemented various sites for employee drop off of recyclable materials.

Reimbursement Specialist/Materials Management

Abbott Laboratories-North Chicago, IL January 2003 – June 2004

Supported Marketing, Research and Development scientists as well as Manufacturing and Warehouse operations.

Conducted order processing, non-product billings and expedited priority International and Domestic orders.

Monitored inventory supply levels and request sampling for testing of incoming products for manufacturing use.

Created and implemented shipping export documentation, commercial invoices, product labels, manifests and Hazardous Material Declarations.

Provided Interdivisional customer service to Hospira, Pharmaceutical Products Division, Abbott International,

New Orleans Distribution and Puerto Rico operations.

Controlled the logistical coordination of solvent transportation from Abbott Chemical Plant and Chicago Recycling Center, including review and approval of payment for transportation services.

Successfully managed a major logistics project for solvent recycling between Puerto Rico and Chicago Safety Kleen. Streamlined the logistics process resulting in significant efficiencies and savings for 2004.

Corrected a billing error resulting in a vendor refund for tanker washes in the logistics billing cycle.

Became certified for DOT Hazardous Material Classification and labeling for Road, Air and Ocean shipments.

Senior Drug Dispenser

Abbott Laboratories-North Chicago, IL March 2001 – January 2003

Controlled pharmaceutical bulk raw material dispensing, label verification and commodity dispensing for Biological manufacturing.

Performed training of warehouse personnel for certification of gas and electric forklift operation for Lake County Operations.

Monitored and maintain temperature recording equipment and acted as safety representative and back up Group-leader for the department.

Safely operated gas and electric forklifts and cube trucks for delivery and transportation of materials to manufacturing.

Chemical Dispensing Technician

Abbott Laboratories-North Chicago, IL February 1999 – March 2001

Recorded and dispensed, received and controlled inventory through inventory system management, including

label and work order packet verification.

Coordinated delivery receipts and returns, issued and allocated chemicals to work orders and performed temperature monitoring.

Conducted On-The-Job training and performed duties as a back-up Training Coordinator for the department.

Safely operated and trained personnel on various types of material handling equipment including high bay and order picking forklifts.

Fill /Label Aseptic Machine Operator

Abbott Laboratories-North Chicago, IL June 1997-February 1999

Operated multiple diagnostic solution filling machines for different size vials, including changeover and set-up of equipment and line clearances.

Effectively setup of linear and peristaltic pumps including in line filtration systems and gravimetrical scales.

Operated filling from various solution containment sources including large tank and roller carriage for magnetic particle filling.

Set up and dispensed human and animal sourced materials including hazardous and radioactive solutions

Education: Currently enrolled in College of Lake County, Business Management

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