MoNique Gonzalez
East Windsor,NJ
Summary
Highly motivated professional with 20 years of business and administrative experience. Possesses extensive knowledge of various roles within the pharmaceutical industry, acquired over a decade. Proactive and driven to take initiative, adept at prioritizing and managing multiple, sometimes conflicting, priorities to meet project deadlines. Demonstrates a proven track record of strong follow-up skills and the ability to execute tasks with minimal direction or supervision. Adapts easily to fast-paced and diverse environments, showcasing an innate ability to work effectively both independently and as part of a team. Dynamic written and verbal communication skills, complemented by excellent customer service and organizational abilities.
Overview
27
27
years of professional experience
Work History
Quality Control and Analytical Services Assoc.
Otsuka Pharmaceuticals
01.2016 - Current
- Company Overview: CBPS contractor - Princeton, NJ
- Data entry of release and stability data for developmental, clinical, and commercial pharmaceutical and related products, both in Labware LIMS and manual tables, ensuring data and regulatory accuracy before submission for approval
- Send samples for approval to the product Project Manager within LIMS system
- Edit stability reports for clinical and commercial products paying great attention to detail
- Import and maintain QC documentation (both internal and external) in GQ-EDMS, including protocols, reports, and test methods
- Perform monthly metrics for each product, receive monthly data from labs and updating tableau report for monthly and quarterly review by Quality Manager and Director
- Review inventory of reference standards for Technical Project Managers, including periodic evaluation of inventory and procuring reference standards as needed
- Perform maintenance management and update of department documents required for regulatory compliance
- Preparation for FDA audits as needed
- Educate team on any new changes and work with IT on any issues or developments with all applications used by the team
- Distribute program and department information, providing support to team members
- Collaborate with various departments to create and revise process documents and standard operating procedures
Business Services Associate /CORE Team
Otsuka Pharmaceuticals
01.2015 - 01.2016
- Company Overview: CBPS-Contractor - Princeton, NJ
- LIMS data entry for Technical Project Managers and Quality Control Team
- Submit vendor verification and payments for exhibits thru Apex system
- Provide back-up administrative support to Executive Assistants and calendar management for C-level executives
- Provide support for various projects as needed ( i.e
- Stakeholder events, New Hire Orientation, All hands meetings)
- Conference room scheduling for on- and off-site meetings
- Provide conference room metrics weekly
- Catering coordination for all internal and external meetings and work functions (i.e
- Stakeholder meetings, Take your child to work day, Quarterly/Kickoff meetings for each department)
Receptionist
Otsuka Pharmaceuticals
01.2013 - 01.2015
- Company Overview: CBPS-Contractor - Princeton, NJ
- Greeted visitors, answered multi-line phone, and directed callers to appropriate department or employee
- Booked conference rooms and handled all off-site meeting room scheduling
- Created and kept track of security access fobs for all employees and visitors
- Assisted in creating standard operating procedures with department management
- Reconciled all UPS shipments and deliveries
- Coordinated logistics for several office moves
- CBPS-Contractor - Princeton, NJ
Administrative Assistant/Travel Coordinator
Niksun Inc.
01.2007 - 01.2013
- Coordinate all domestic and international travel and accommodations for CEO, Vice Presidents, Managers, and prospective employees using Amex Travel
- Preview resumes, prequalify prospective employees, schedule interviews and synchronize hiring efforts with recruiters and Human Resources
- Conduct final review of expense reports before submission and assist HR director with all projects as needed
Account Coordinator
Rotor Clip
01.2000 - 01.2007
- Managed 60+ customer accounts
- Provided price quotes
- Inventory updates
- Provided customers with product knowledge and material safety data
- Trained new employees
- Processed purchase orders
- Substituted for manager and receptionist as needed
Bill Processor
PSE&G
01.1998 - 01.1999
- Performed data entry of meter readings using customized billing software
- Processed invoices and payment checks
- Assisted with mailroom duties
Education
Certificate - Fashion Merchandising
Katherine Gibbs
Piscataway, NJ01.2006
Skills
- Proficient in MS Office 365
- Concur
- LIMS
- GQEDMS
- Mondaycom
- Data Studio
- Amex Business Travel
- On/Off site conference room scheduling
- Domestic/International travel coordination
- Ability to learn customized databases quickly and efficiently
- Excellent communication skills
- Strong ability to work in a team environment or individually
- Courteous and Professional
- Event Coordination
- Calendar Management
Phone
cell, (732) 266-7726
Timeline
Quality Control and Analytical Services Assoc.
Otsuka Pharmaceuticals
01.2016 - Current
Business Services Associate /CORE Team
Otsuka Pharmaceuticals
01.2015 - 01.2016
Receptionist
Otsuka Pharmaceuticals
01.2013 - 01.2015
Administrative Assistant/Travel Coordinator
Niksun Inc.
01.2007 - 01.2013
Account Coordinator
Rotor Clip
01.2000 - 01.2007
Bill Processor
PSE&G
01.1998 - 01.1999
Certificate - Fashion Merchandising
Katherine Gibbs
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