Project Management Quality Assurance
Resume:
Willeasa J. Orha
*****************@*****.***
Rocky Mount, NC 27804
Professional Summary
Client focused and results-driven Administrative, Manufacturing, Quality, and Compliance professional with over 30 years of GMP Pharmaceutical/Automotive experience with fortune 500 companies. Able to efficiently multitask while staying organized and maintaining attention to detail. A quick learner who is adaptable and works effectively with minimal supervision.
Areas of Expertise
•Quality Assurance; cGMP Environment, Quality Systems, 21 CFR Part 11 and SOP’s
•Legal and Regulatory Compliance; ISO 9001:2008/ISO 13485:2003 Guidelines/Regulatory Standards (ICH, FDA, WHO, EU Directives, PIC/S)
•Logistics Supply Chain Management
•APQR’s, Monthly SQ Metrics, MRB Coord.
•Batch Records/Change Management/CAPA
•Risk Management
•Project Management
•Lean Six Sigma
•Customer Relations Skills
•Computer, phone, fax/print/scan skills
•Inventory Control/Sample Management
•Notary Public
Education
Cuyahoga Community College, Corporate Division Ohio
Quality Boot Camp Training Program Feb 2014-Apr 2014
Applied Project Management (40 hrs.)
Lean Six Sigma Green Belt (100 hrs.)
Mastered Program Competencies and Trained To:
•Prepare, manage and lead Lean Six Sigma projects within an organization
•Identify and implement lean and project management tools for process optimization
•Plan a project and its phases through estimates, assessments, analysis, and scheduling
•Measure ROI for projects and organize, present and evaluate milestone reviews
•Determine project parameters that impact business needs and organizational requirements
University of Phoenix
Associates of Arts Degree in Pharmaceutical Practice May 08-June 10
Professional Skills and Qualifications
•Support and conduct legal and regulatory supplier compliance reviews and audits for Process Improvement, Change Management, and Risk Management.
•Collect, analyze and summarize information to produce reports.
•Maintain quality service by establishing and enforcing organization standards and assisting staff with implementation of continuous improvement initiatives
•Make recommendations for process improvements to prevent recurrence of compliance errors
•Construction Project Management
•Sample Receipt Tracking/Controlled Substance Coord. /Conduct EHS lab inspections
•Operate and maintain autoclave for equipment sterilization; perform terminal and post sterilization of medical and pharmaceutical supplies
•Manage databases, maintain files and records and perform data entry
•Research and secure vendor contracts for inventory control and purchasing
•Managing Approved Suppliers List (ASL) in an FDA regulated industry
•Customer Service duties, answering phones, filing, data entry, invoicing, billing
•Experienced in harness design/installation and DVP processes
•Electrical repairs: various types of connectors; Deutsch & Tyco
•Use of digital multimeter, checking continuity of circuits
•Problem solving and customer relationship skills
•Loan closings such as loan modifications, refinance, reverse mortgages, Power of Attorney, Living Will, residential/commercial/industrial inspections
•Assist property owner with leasing property by processing rental applications
•Move-in, move-out inspections, pest control
•Tenant screening includes not limited to, background/credit checks
•Marketing of rental properties
•Scheduled tours of available properties
•Handled collection of rent payments
•NNA Certified Mobile Signing Agent
Notary Public Rocky Mount, NC
Certified Mobile Notary Apr. 2008-Current
OIC, Inc. Rocky Mount, NC
VABS Project Manager Sept. 2022-Apr. 2024
Manage tenants leasing warehouse space, create leases,
maintain tenant contracts and contact info. Manage
construction projects, schedule and conduct pre-con
inspections with State of NC, track and ensure project
remains on schedule, order construction materials, schedule
hotel accommodations, and per diems.
aFreshnewStart, LLC Rocky Mount, NC
Leasing Agent Oct. 2021-Mar. 2022
Process rental applications, show available properties,
move-in move-out inspections, oversee daily maintenance
work requests
Home Solutions Real Estate Services, LLC Rocky Mount, N.C
Owner-Investor Sept. 2015-Jan. 2018
Real Estate Investments
Leoni Wiring Systems, Inc. Rocky Mount, N.C
Supplier Quality Engineer Nov. 2016-April 2020
Tech and quality support of the customer,
Customer spec requirements, zero defect requirements,
processing and coordination of customer complaints,
corrective actions and follow-up meetings, coordinate repair
and or sorting activities onsite, involved in optimization
of harnesses for cost, production and quality issues.
Interface to QM, series development and customer; Be part
of the evaluation on parts returned as a warranty
Kelly’s Services (Hospira, “A Pfizer Company”) Rocky Mount, N.C
Quality Engineer June 2014-Oct. 2016
CVS Caremark Strongsville, Ohio
Pharmacy Technician Oct. 2013-Nov. 2013
Ben Venue Laboratories, Inc. Bedford, Ohio Compliance Analyst/Co-Auditor, December 2012 - December 2013 Oct.1989-Dec.2013
Compliance Support Specialist, January 2010 -December 2012
Sr. Laboratory/Administrative Assistant, August 2003 - January 2010
Laboratory Assistant, April 1992 -August 2003
Pharmaceutical Technician, October 1989 - April 1992
Volunteer
Southwest General Hospital Berea, Ohio
Emergency Department Liaison Volunteer Jan. 14-May 14
Greet and orient patients, families, and visitors, providing clear explanation of procedures and processes. Check on patients and provide comfort items. Maintain cleanliness and order of waiting areas.
Computer Skills
Microsoft Office, MFG-PRO, Basic Powerpoint, AMMS and SharePoint, SAP, AS-400, Trackwise, Zoom
Certificates
•ISO 9001:2008 Certified Internal Auditor Training
•Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
•Quality Boot Camp – Lean Six Sigma/Project Management Certified Lean Six Sigma Green Belt
•Certified Mobile Notary
•Basic Electrical Certification
Professional Affiliations
•Notary Public (Ohio-2008), (North Carolina-2015)
•National Notary Association, Notary Rotary, Notary Café
•Triangle Real Estate Investors Association (TREIA)
Contact this candidate