Tanisha Harris

(New Jerssey and available for remote opportunity)

Summary:

A qualified and dedicated administrative (health) professional with the ability to work as a team member in a fast-paced environment. Seeking to advance my career utilizing previous work experience with the opportunity to develop my skills and further my knowledge. Organized and detail orientated team player able to work effectively on multiple projects simultaneously.

Experienced working effectively across functional areas with representatives at various levels. Adaptable and willingness to learn to advance my skills sets to be a productive asset to the company.

Review and approve controlled documents like test methods, client protocols, stability studies, material qualification, document change controls (DCC), and document change requests (DCR).

Generated and revised internal and external documents including SOPs via SAP, BPRs (Batch Production Records),

Generated a metrics report for uncompleted SOPs, WPs etc. for DCC/DCR.

Education:

Associate Degree - Applied Science Health Information (GCP) PHI Clinical Data; DeVry University, North Brunswick, NJ. 2009 – 2011

Software Applications Experience

ComplianceWire

SuccessFactor

Concert One

Citrix Apps Rome

Great plane

MS Suite: Word, Excel, Power Point

Image X

ProveIT Testing: Data Entry Alpha Numeric – 8,045 KPH

Copy/Scanning

Professional Experience:

Pfizer- N.C. (Contractor) Nov 2023 – Mar 2024

Remediation Training Administrator Specialist

Coordinate resolution of compliance issues in collaboration with functional areas.

Developed and updated training materials, manuals, and documentation.

Conducted training sessions for employees, ensuring compliance with industry standards and regulations.

Collaborated with cross-functional teams, SMEs, and area managers to identify training needs and create the right size curriculum for the role.

Monitored and assessed the effectiveness of training programs, making necessary adjustments for improvement.

Maintained records of training activities and employee progress.

Assess and redesign site curricula (focus area Quality and Operations – approximately 1000 total).

Eliminate duplicate curricula – develop curricula by work task, and department area.

Overhauled conventional training approach to enhance effectiveness through module redesign.

Merck-Rahway N.J. (Hybrid) Feb 2023 - Oct 2023

Quality Compliance Administrator

Track, manage and report compliance related activities in collaboration with the Quality Organization (e.g. training, compliance, audit response preparation, SOP periodic reviews).

Coordinate inspection activities and assist areas in maintaining a state of inspection.readiness.

Coordinate resolution of compliance issues in collaboration with functional areas.

Administer the SOPs and supporting documentation (e.g. Forms. Job Aids, SOP deviations).

Provide draft template, keep tracking database up to date, make docseffective or inactive.

Author/review/contribute to SOPs to ensure compliance commitments areappropriately incorporated and timelines are met.

Assure adherence to Records Management and other Documentation system requirements.

Coordinate, development and maintain learning plans and assure consistency across Organization

Administer the training system (request training materials to be uploaded in the system,make and verify employee, curricula, and job position data changes in learning system,run reports.

Monitor that functional area employees have attended mandatory/relevant training and advise management of training compliance status and related training issues.

Gilead Science – Foster City CA (Remote) Apr 2021 – May 2022

QA Documentation Specialist – II

Support compliance with the IT Training Administration Program by supporting IT Staff with the assignment of GxP training creation and maintenance of training curricula review of document training assignments

creation and maintenance of training records, and assisting IT staff with general training queries

Monitors department mailbox, addresses and resolves customer questions promptly, maintains close cooperation and communication with globally dispersed personnel

Enters training completion data and training records into the Training System

Provides quality oversight through review and analysis of records/data for compliance and consistency with procedural and regulatory standards

Review and approve controlled documents like test methods, client protocols, stability studies, material qualification, document change controls (DCC), and document change requests (DCR).

Generated and revised internal and external documents including SOPs via SAP, BPRs (Batch Production Records),

Generated a metrics report for uncompleted SOPs, WPs etc. for DCC/DCR.

Performs quality control of entered data and follows appropriate procedures to ensure the quality of information contained in the Training System

Provides ongoing user support/training on system(s) and department processes Supports the periodic review of training courses and training curricula. Running reports

BMS (Celgene) – Summit NJ. October 2019 – April 2021

Global Quality Training Specialist (Contractor)

Work with electronic document and learning management systems.

Perform administration and maintenance activities for employee ComplianceWire accounts.

Create/modify User Groups and Curriculums.

Process user queries/requests received via the help desk ticketing system.

Perform day to day tasks in the electronic document, IT ticketing system and learning management systems (i.e., Veeva QualityDocs, ServiceNow, Celservice ComplianceWire, & SuccessFactors).

Ability to communicate effectively across various functional areas.

Provide reports/queries and perform other functions (for example projects) as assigned.

Allergan – Branchburg, NJ Apr 2019 - Aug 2019

Quality Trainer (Contractor)

Responsible for planning, managing and appropriately delegating essential base-business tasks and project activities pertaining to training for the Allergan Branchburg site

Training lead for New Hire Orientation including new hire training plan creation, updates etc.

Maintain the electronic training system (ComplianceWire)

Ensure ComplianceWire data is consistently accurate and up to date

Periodically review training administration procedures to ensure alignment with current site initiatives, regulatory body requirements (FDA, DEKRA, and AATB) and Global Corporate training procedures

Develop criteria to evaluate the effectiveness of training activities, including quizzes, surveys, and process confirmation observations

Apply Information Technologies to processes and learning that result in an overall improvement in quality, effectiveness, and efficiency

Building access forms & approvals

Caring with Compassion - Eatontown, NJ Aug 2018 Apr 2019

Support Coordinator

Supporting adults with mental health conditions with day-to-day activity

Helping clients deal with day-to-day emotions

Guidance & mentoring of Developmental Disabilities clients

Helped clients to obtain their daily goals

Provided hearing impaired translation

Iron Mountain- Freehold, NJ Feb 2018 - Jul 2018

Document Specialist Team Lead (Contractor)

Managed the day-to-day operations of 14 people preparing documents to be scanned for electronica use (Electronica Records)

Performed Quality Assurance by checking accuracy of documents matching file information

Prepared documents to be scanned

Prepared boxes for storage

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