Carla Woolever
Fort Wayne,IN
Summary
Document Control Specialist experienced in storing, managing and maintaining company and project documents while ensuring accuracy and quality. Process documents for revision and approval, organize documents from conception to distribution and filing and create systems to be used to train staff on document control processes. Growth mindset and willing to help team move business forward with any task.
Overview
12
12
years of professional experience
Work History
QA Document Control Specialist
Cue Health
04.2021 - Current
- Maintain and facilitate the change order system and document control system
- Support collection, maintenance and storage of the quality system and medical device product records including but not limited to DHR, DMR, WI, SOP, Forms, etc
- Support training program for QMS and GDP
- Created a training online video for QMS and GDP process
- Ensure compliance to ISO13485, 21CFR820, 21 CFR Part 11
- Assisted in audits
- Support onboarding and off boarding of all employees
- External supplier notifications
- Provided administrative support within the Quality Assurance Department.
- Streamlined document control processes by implementing efficient organization and filing systems.
- Collaborated with cross-functional teams to maintain accurate, consistent, and high-quality documentation standards.
- Conducted training sessions for new employees on document control procedures, ensuring consistency across departments.
- Contributed to company-wide process improvements by providing expert insights on document control best practices.
- Promoted a culture of continuous improvement by regularly soliciting feedback from colleagues regarding document control processes.
Quality Project Coordinator / Document Control
Abbott
07.2016 - 09.2019
- Implemented remote environmental validation process resulting in 1.5 MM cost avoidance
- Trained internal and remote personnel on validation protocols and procedures
- Coordinated and performed onsite and remote validations
- Created IQ and OQ validation protocols
- Generated validation reports and address non-conformances
- Managed schedules
- Maintained records for suppliers and equipment
- Ensure compliance to ISO13485, 21CFR820, 21 CFR Part 11
- Maintained supplier qualifications and requalification
- Updated and sent supplier surveys
- Maintained approved supplier list
- Reviewed and maintain NCR, rework and other QA trend reports
- Supported and performed on-site audits
- Created document revision, distribution, obsolescence, and retention activities
- Generated, reviewed and managed protocols for QA and Operations
- Completed Leadership Fundamentals Program with Center for Creative Leadership.
Executive Assistant
Charco Build & Design
04.2015 - 01.2016
- Recovered over $30,000.00 from unpaid accounts by rectify bookkeeping records
- Improved over 200 vendor relationships
- Managed schedules for CEO, COO and five employees including meetings, travel, clients and personal appointments
- Developed comprehensive filing system
- Maintained onsite vendor documents including insurance verification, payroll documents and OSHA compliance
- Transcribed and disseminated meeting minutes to CEO and COO.
- Streamlined executive communication by managing emails, phone calls, and scheduling appointments.
- Maintained confidentiality with sensitive documents, ensuring proper storage and distribution as needed.
- Improved office efficiency by implementing new filing systems and document management processes.
- Coordinated events for staff members, promoting team-building activities and boosting morale within the workplace.
- Prepared and edited presentations on behalf of executives for both internal meetings and external conferences.
- Developed strong relationships with vendors leading to improved contract terms resulting in cost savings for the company.
- Handled confidential and sensitive information with discretion and tact.
Administrative Assistant
Patrons of the Prado
01.2014 - 01.2015
- Improved record keeping and document referencing for donations, sponsorships and event planning
- Created and managed documents
- Managed calendar
- Transcribed and disseminated meeting minutes.
- Enhanced office efficiency by streamlining administrative processes and implementing organizational systems.
- Improved document organization with thorough file maintenance, archiving outdated records as necessary for efficient retrieval when needed.
- Optimized calendar management for executives by scheduling appointments strategically while considering priorities and minimizing conflicts.
- Transcribed and organized information to assist in preparing speeches and presentations.
Office Manager
CCS Services
03.2012 - 01.2014
- Managed 14 employees including scheduling, payroll, insurance and OSHA compliance along with conflict resolution and team building
- Recovered $64,000 from past due accounts and maintained accounts receivable and payable for more than 150 properties
- Reduced marketing spend by nearly 75% through auditing of costs and services
- Increased customer base over 30%
- Managed insurance certificate requests, COI, workers compensation and auto claims.
- Streamlined office operations by implementing efficient filing systems and organizational strategies.
- Reduced costs with meticulous budget monitoring and expense tracking for essential supplies and equipment.
- Managed vendor relationships, negotiating contracts for cost savings while maintaining high-quality services.
Education
Some College (No Degree) -
Mira Mesa College
San Diego Skills
- Records Management
- Document Review
- Document Management
- Document Formatting
- Quality Assurance
Websites
Timeline
QA Document Control Specialist
Cue Health
04.2021 - Current
Quality Project Coordinator / Document Control
Abbott
07.2016 - 09.2019
Executive Assistant
Charco Build & Design
04.2015 - 01.2016
Administrative Assistant
Patrons of the Prado
01.2014 - 01.2015
Office Manager
CCS Services
03.2012 - 01.2014
Some College (No Degree) -
Mira Mesa College
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