Call Center Quality Engineer

Vanessa P Bruce

**** ***** ******* **.**, Albuquerque, NM 87114

*************@*****.***

609-***-**** or 505-***-**** (Cell)

Summary:

Solid experience in cGMP, GCP & GLP, quality assurance, compliance, training, auditing, curriculum development and marketing.

Well versed in CFR 21 Parts 210 and 211 and Part 11, 21 CFR 820 as well as ISO 9000, ISO 9001 and all ICH Guidelines.

Dedicated agent of change who identifies inefficiencies and structures solutions that optimize performance. Designed Access database to track monthly training reports of 5 departments.

Seasoned facilitator comfortable in presenting before diverse audiences and in varied environments. Developed and provided monthly training courses to 8 team leaders for Train the Trainer using ADDIE Model Learning and Adult Learning Theories.

Designed and Implemented E-Learning, Classroom Training as well as self lead training to over 3,000 employees.

Resourceful and detail-oriented with successful results in identifying curriculum deficiencies at 8 global sites; developed new system affecting over 3000 employees.

Recognized for outstanding work ethic and promoted through positions of increasing responsibility. Highly organized leader able to prioritize tasks and deliver top quality products within tight deadlines

Independent and self-motivated with excellent research and writing skills; able to grow positive relationships with

clients and colleagues at all organizational levels.

ICD-9 Codes, ICD-10, DSM V

Experience:

The Providencia Group (Government Contract, Office of Refugee and Resettlement) March 2022 - Present

Trainer/Curriculum Developer

Lead Individual or group instruction of adult learners

Facilitate training sessions(s) through a variety of modalities

Update training material(s), as needed

Assist with creating content, collecting data, and evaluating training effectiveness

Coordinate training scheduling and records maintenance

Develop training curriculum and materials

Travel to training sites for in-person delivery, as scheduled

Ascending Hope Guardianship, LLC January 2015 - June 2021

Ascending Hope, LLC

Owner/CEO

Corporate Guardian to clients throughout New Mexico

Work with clients to gain access to benefits, housing ect

Work to ensure the clients are receiving services that fall in line with their rights

Help to ensure the Least Restrictive Alternatives are being met

Work as a Court Visitor where I advocate for the potential Ward

Access the need of the Guardianship and make recommendations to the Judge of whether the Guardianship is in the clients best interest

A.L.I.V.E. INC., Rio Rancho, NM

Training Director January 15 – February 2018

Design and facilitate trainings for all level of staff

Write company Policy and Procedures

Primary contact for Healthcare Providers

Determine medical necessity of prospective behavioral clients

Use and understand medical terminologies to write clinical for submission to Healthcare Providers for client Authorization

Treatment Guardian for a client with mental health disabilities to determine proper psychotropic medications

Coordinate staff schedules to ensure all shifts are covered

Design and implement medication and treatment protocols for all new clients

Assess budgets for clients as well as staff

Work closely with Psych for client medication regimen

Use ICD-10 to code diagnosis

Develop treatment plans for clients with Mental Health and Behavioral Disabilities.

Perform Quality Checks for Medication Management Medication Management

Optum Health, Phoenix, AZ

Training and Quality Operations Manager for the Phoenix Site April 14 – January 15

Maintain up-to-date knowledge, training and applicable certification and licensure on designated content and course material as identified by University Director. (e.g. systems, products, processes, procedures, sales, leadership, training, soft skills, customer care skills etc.)

Deliver classroom training programs on various topics such as sales, service, quality, leadership, management, training, presenting, etc.

Administer course tests, assessments and surveys to evaluate training effectiveness and future needs.

Coordinate class schedules and commensurate logistics.

Participate in design of courseware, CBT and general training content development.

Participate in design of tests, assessments and surveys.

Participate in execution of departmental training needs assessments.

Manage and lead operations training staff to accomplish operations training goals as well as to identify emerging training gaps and needs.

Manage and lead Quality Analysts and support staff in order to achieve daily customer interaction observations and scoring standards and requirements.

Manage all training and quality programs within all lines of businesses

Lead and develop all trainers and quality analyst

Brookline College & University of the Potomac, Phoenix, AZ

Project Manager (consultant) July 13 - November 13

Design and develop marketing packets for the 8 campuses I am responsible for

Find and work with outside vendors to review and change the college curriculum

Go to the campuses to asses what some of the issues are and work with the directors and presidents to make changes

Working with the VP’s President, Investors and the CEO to develop strategies and manage project direction

Write monthly blogs for each campus monthly

Responsible for all the marketing for the schools

In charge of and responsible for the delivery of all the projects from all campuses to ensure they are completed on schedule and correctly

CIS (Compliance Implementation Services), Newtown Square, PA November 12 – January 13

Sr. GMP Compliance Specialist (Consultant)

Develop CIS Communications (Blogs, Podcast, Articles to be published in Pharma Magazines and webinars) Some are to include Risk Assessments and Inspection Readiness but not limited to

Review and Approve Audit Reports from the Sr Auditor at one of our client sites

Support the close out of client specific work

Complete GMP Training Module

Organize the training for the Board of Directors

Review, Rewrite SOP’s from clients while doing a GAP Assessment

Write Marketing Fact Sheet on all sections of the business

Review redacted sheet of the manufacturing sales sheet

Compile and overall report on each client SOP

Perform interviews with client

Laureate BioPharma, Princeton, NJ

Quality Assurance Specialist/ GMP Trainer (Consultant) July 11 – November 12

Supports and directs QA management to ensure product quality and compliance with cGMP’s.

Develop and Implement a companywide Documentation Quality System.

Write a Corporate Quality Manual.

Write, review and update SOP’s and Policies.

Root Cause Analysis

Wrote the CAPA SOP.

Design and Develop Design and Process Flow Charts.

Design and Develop Gantt Charts.

Support the Operations all groups with issues of compliance to establish Company Policies, Regulatory guidance or client specific requirements.

Support QA management in periodic internal and external audits as needed.

Assist in assuring through deviations/investigations through review and development assistance and ensures CAPAs are implemented and tracked to completion.

Conducts cGMP Training; development of Training Plan and Training Programs.

Support QA Management with Client and Regulatory Audits.

Leads the Sr. Documentation Coordinator.

Trains departments as needed on GMP Training.

Managed the documentation staff

Johnson & Johnson Skillman, NJ (Consultant) June 10 – April 11

Quality Engineer III

Support External Manufacturing QA Compliance in J&J Consumer and Personal Products Worldwide

Responsible for ensuring ongoing Contract QA compliance management functions are met, with the primary function of managing the Marketed Product Stability (MPS) program and writing Annual Drug Product Reviews (ADPR's)

Responsible for participating in cross-functional teams with Technical Assurance, Operations, Marketing & R&D

Responsibilities include reviewing periodic report of key quality indicators and provide analysis of data to QA management and other functional groups

Support the External Manufacturing QA group as needed

Reviewed and updated the Quality Responsibility Agreement Template for all External Manufacturing Sites working with Upper Management of the site

Back-room support for Corporate Audit

Leading a Medical Investigation Report for an Product Complaint

First Article Inspection report writing

Validation Report Review and approve

Product Transfer and Release

Nonconformance Investigation

CAPAS review and initiate

Audit Observation response from External Manufacturer

Thermo Fisher Clinical Services, Allentown, PA February 08 – February 10

Corporate QA Compliance Trainer, North America

Developed training programs associated with new or revised regulatory requirements, system implementations, and emerging business practices resulting in timely and compliant deployments globally

Trained the Quality Sales Force on Policy and Procedures, Sales Techniques and Regulations

Developed Firm’s SOP’s to ensure compliance with US cGMP and GCP standards and requirements and Quality System Elements (QSEs) which include conformance standards using Documentum (Electronic Database Management System)

Design and delivered Trainings via classroom, E-Learning and self paced for all sites within North America

Collaborated with senior management and vendors to creatively design and develop adult learning solutions and communication materials that were impactful, accurate and promoted the Firm’s vision

Facilitated monthly internal Quality Unit audits to ensure compliance

Customized values and policy messages, training materials to meet the needs of a broad range of audiences

Collaborated with vendors to embed company policies and align functional training with business ethics and value objectives

Reviewed investigations for accuracy and compliance with regulatory requirements

Maintained and developed firm’s website and monitored usability recommendations

Was a member of leadership teams for several pilot programs globally to develop firm-wide global compliance procedures and best practices; launch organization’s new intranet site; implemented cGMP training program globally

Assessed strengths and weaknesses of compliance training to develop best practices and meet regulatory guides

Authored/ updated numerous SOPs; achieved proficiency in various analytical tools and instruments

Managed a staff of 10 Master Trainers over 8 sites Nationally

Accomplishment: Developed, Designed and implemented a cGMP E-Learning, classroom and self paced program to be used in all sites nationally and internationally for over 3,000 employees using ADDIE Model Learning and Adult Learning Theories.

Lonza Pharmaceuticals Conshohocken, PA June 06 – February 08

Sr. Quality Associate

Analyzed data for unusual trends/discrepancies and developed new SOP’s to correct the problem

Developed, scheduled, delivered, documented and tracked, cGMP and technical E-Learning and web based training for manufacturing, leadership, general staff and engineering based on Adult Learning Theories.

Performed regulatory reviews: ISO, ICH, Q10 and Q9

Developed database for Batch Record Review using Six Sigma principles

Trained staff on cGMPs in the manufacturing plant as well as general office staff

Liaised with corporate divisions to facilitate flow of information across firm

Due diligence review/competitive assessment of environmental products within the manufacturing plant

Developed validation protocols for complex product/environmental sample.

Facilitated FDA audits and implemented procedures to include audit observations

Investigated laboratory test results for non-conformance to cGMP specifications and regulations

Generated monthly/ weekly tracking reports for senior management

Accomplishments: Promoted from Temp to Perm within two months, and then promoted to the Lead of Documentation Department within another 3 month. Was made a Sr. QA Associate and Training Manager within 6 months, and then named the fastest growing employee in the company. Decreased deviations and nonconformance’s by 1/3 through Six Sigma methodologies

Backroom support for two FDA audits

Wrote technical SOP’s and Batch Records for the production staff

Managed a staff of 15-20 documentation individuals

Shire Pharmaceuticals Chesterbrook, PA August 04 – June 06

QA Compliance Associate (contractor)

Reviewed QC results against product specifications to ensure they meet approved specifications

The initial contact for consumers who called in with product complaints

Responded to product inquiries nationally and internationally by phone to assist in helping to resolve questions or to escalate the issue to the appropriate areas

Received calls from external consumers which included adverse events, where product knowledge and expertise was a critical part of helping to find the root cause

Collected, reviewed and entered complaints into SAP tracking database.

Proactively identified potential issues and provide resolutions

Worked with SME’s to review and write investigations and CAPA’s

Made recommendation to upper management about product labeling which cut down on product complaints

Found out what the issues were tried to problem solve and if we could not then the call would be transferred to the next tier to callers who had more extensive knowledge.

If my group was not helpful then we had another tier of medical professionals.

My goals were to always have my group so knowledgeable about the product that they would not have to transfer to another person and I was successful in this.

In total there were about three hundred call center people not all in one location which made it a bit more challenging

I did not manage that many one on one I had several supervisors in the different tiers who at the end of the day would talk about the issues and try to resolve them before they became a huge problem then train the staff on how to avoid or deal with those issue.

In addition part of my job was to train people who were having difficulty with their calls because either they did not understand the product or they were not sure how to defuse the caller to get the information.

Root Cause Analysis

Additional Experience:

Philadelphia Workforce Development Corporation Philadelphia, PA January 02 – May 04

Operations Manager/Facilities Supervisor

Supervised and Trained Administrative and Facilities Staff

Maximizing Participation Project (Project) Philadelphia, PA

Raymond Karsan Associates Wayne, PA January 98 – December 01

Executive Recruiter/Performance Supervisor

The Development Center Philadelphia, PA January 95 – January 98

Call Center Supervisor, Trainer and Account Manager

Managed inbound/outbound cold calling center up of to 200 callers at a time

Managed calling campaigns.

Account manager of several campaigns at one time.

Ensured callers met their numbers through real time training.

Taught sales techniques as part of the on boarding of new employees.

Root Cause Analysis

American Life Insurance, Conshohocken, PA January 93 – January 95

Insurance Sales/Supervisor and Trainer

Field trained up to twenty agents at a time teaching them Life, Health and accident insurance

Classroom trained up to 20 classes a month

Managed, Maintained numbers for and trained about 20 agents at a time. In the field and in the classroom.

My group became so successful that we became the 3rd top sellers in the nation in 3 months

United States Army 1990 – 1998

Chemical Operations Specialist

Voyage House 1989-1999

Youth Counseling Agency Chair person

Skills: MS Word, Excel, PowerPoint, Lotus Notes, Publisher, Quick Books, Novell, ICCS, EMARS, PDM1, SAP, CAPA, Trackwise and Documentum, Captiva, SharePoint. Kronos, VISIO

Education/ Certification:

Legal studies, preparing for my JD in Regulatory Law at Kaplan University, 2012

Business Administration, Temple University Philadelphia, PA, 2002

Business Administration, Pierce College, Philadelphia, PA, 1999

Six Sigma Green Belt Certified

Train-the-Trainer Certified

Certified Internal Auditor

Project Management Certified

Certified in Instructional Design

Board Member of the Black Board of Directors

President of the National Association of Professional Women of Phoenix, AZ

Personal Trainer Certified

CPR Certified

Certified Registered Behavior Technician

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