Christina Roesing
Consultant/Auditor
PLAINFIELD,IL.
Summary
Accomplished Consultant that drives organizational improvements through leveraging expertise in research and system enhancement. Performed multiple mock audits for FDA 21 CFR 210/211 - Drugs, cGMP, FDA 21 CFR 58 - GLP, and Non-Conforming & CAPA FDA/ISO compliance. Audited for Safety, Hazard Analysis, and EHS for many well-known businesses to improve meeting and exceeding a real audit for FDA and OSHA inspections. Well-versed in collaborating with employees and leaders to resolve control and procedural problems negatively affecting business operations. Willing and able to train applicable employees to perform internal audits both professionally and diligently to comply with all rules and regulations necessary. Dedicated to cost, process, and resource optimization.
Overview
14
14
years of professional experience
Work History
Business Owner
Three Red Rules LLC
05.2023 - Current
- Conduct audit inspections and independent checks to verify parts and materials for contracted Manufacturers.
- Train manufacturers' employees to adhere to regulatory and policy changes and make adjustments to maintain overall success.
- Train on creation/review/and revisions of SOPs to increase performance results and be GMP compliant.
- Train for OSHA and FDA inspections and audits by performing mock audits and review and CAPA of audit findings.
- Perform audit and implementation of Safety team and safety compliance.
- Cultivating and strengthening lasting client relationships using firm issue resolution and dynamic communication skills through established contractual agreements and NDAs.
- Manage all contracts, NDAs, audit agendas, audit questionnaires, and audit findings report along with any training documents with certificates provided upon completion.
Internal / External Auditor
Self Employed
11.2022 - 05.2023
- Prepare Audit Agendas, Audit questionnaires, Audit Checklists and Audit Findings Reports both internally and externally during previous employment and currently for Major companies with NDAs signed.
- Performed and lead auditing process and required demonstrations from laboratories and production to match SOPs.
- Assisted Major Companies as well as auditing their 3rd party suppliers to asses/review and revise all SOPs fully to ensure they meet all applicable regulations and guidelines.
- Created and delivered training for junior auditors on correct procedures internally for Major companies.
- Verified accuracy, compliance, and completeness of team auditing work.
- Recommended strategies for improving compliance and success of internal controls.
- Assessed company controls and potential risks against benchmarks.
- Conveyed complex audit information to clients of diverse backgrounds.
- Prepared working papers, reports, and supporting documentation for audit findings.
QC LABORATORY MANAGER / SAFETY MANAGER
Terraboost Media Tazza Brands
07.2021 - 10.2022
- Kept laboratory in compliance with applicable guidelines and laws
- Interviewed, hired and trained lab technicians to perform experiments and analyze results
- Set and oversaw quality assurance guidelines for laboratory work
- Managed operational documents and produced reports detailing activities
- Managed safety team and held quarterly meetings.
- Conducted daily hazard analysis reports, while delegating employees to conduct them for area assessments to begin their duties upon receiving validation of signature from myself.
- Kept equipment maintained, facility clean and organized and inventory stocked to maximize performance
- Trained staff, scheduled work hours and assigned projects for our work group
- Designed processes to increase efficiency by minimizing error and reducing repetitive tasks
- Resolved issues with product development from inception through 3 post-commercialization processes
- Developed and tested formulas for over 15 products to find high quality, low cost options
- Executed corrective actions when test controls were outside specified limits
- Carried out day-day-day duties accurately and efficiently
- Overseen production processes and quality concerns / issues.
QA LAB TECHNICIAN / Food and Safety
Costco
02.2018 - 06.2021
- Analyzed and interpreted test data and determined performance and reliability of materials
- Conducted inner inspections within production and laboratory
- Maintained clean and sanitized laboratory for smooth workflow by performing everyday policies and procedures
- Monitored and provided input into improving efficiency of processes and procedures
- Analyzed issues and recommended corrective actions to improve final results
- Monitored and upheld safe operating procedures and clean area mandates to meet regulatory requirements
- Participated in technical trainings and retraining to improve skills set and boost overall knowledge
- Conducted time framed tests on product samples and recorded results
- Performed quality control inspections at customer sites to determine alignment with safety regulations
- Maintained laboratory equipment to keep tools functional
- Evaluated fat samples, colorimeter samples and positive/ negative test results against quality requirements to maximize efficiency.
QA LEAD
WeatherTech
08.2017 - 12.2017
- Gathered and input data on required labeled documents to ensure results were recorded properly in daily paperwork
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction
- Improved quality processes for increased e ciency and e ectiveness
- Inspected and repaired products to meet project expectations
- Recognized defective material and reported issues to management
- Moved items between machines, conveyors, ovens and transport equipment to meet production needs
- Examined final products for conformance with quality and design standards
- Inspected Incoming raw materials shipments for compliance with quality standards agreed upon in vendor contracts, reporting discrepancies as necessary
- Identified deviations in finished products from quality standards, isolating 4 causes within the production process and devising solutions to increase consistency.
MARKETING MANAGER
NRG Home Solar
01.2017 - 06.2017
- Exceeded sales and profit goals by supervising marketing and planning activities
- Developed and implemented digital marketing plans to incorporate SEO
- Social media platforms and video campaigns
- Researched market competitors to identify potential new products and service opportunities.
STORE OPENER|Dollar Tree INC
01.2013 - 10.2016
- Trained and developed over 50 employees in each store I was assigned including but not limited to store managers, assistants and employees that would be sta ed
- Supported store openings by proper preparation and action, ensuring everyone was trained on time and the store was set up and filled to plan-o-grams completed by corporate
- Ce regulations
- Ordered all store merchandise to start the store with accuracy by verifying inventory procedures
- Conducted department walkthroughs to assess and remedy factors such as cleanliness, inadequate stock levels and proper merchandising.
STORE MANAGER
Dollar Tree Inc
06.2009 - 01.2013
- Delivered excellent customer service and adhered to standard practices to maximize sales and minimize shrinkage
- Processed daily paperwork, balanced register drawers, produced staffing schedules and prepared deposits
- Managed inventory tracking and physical inventory counts to minimize loss
- Balanced sales, reconciled cash and made bank deposits to facilitate opening and closing duties
- Generated repeat business by responding to customer concerns with friendly and knowledgeable service
- Oversaw inventory management through cycle counts, audits and shrinkage control
- Prioritized sanitation, safety and health standards in work areas to meet
- OSHA requirements met
Education
Bachelor of Science - Bachelor of Science in Buisness Administration
Colorado Technical University
Colorado Springs, CO02.2024
Environmental Health And Safety - OSHA Safety Management Training
OSHA
Joliet, IL09.2022
Buisness Management - Certification
Management
Downers Grove, IL07.2007
Associate of Science - Science, Technology, And Society
Joliet Junior College
Joliet, IL02.2003
Skills
- Management
- Supervision
- Business Operations
- Managing Laboratory
- Operations
- Auditor for Manufacturers
- Laboratory Computer System
- Laboratory Information System
- (LIS)
- Logging Samples in Laboratory
- System (LIMS)
- LIMS Temperature and
- Incubation Hourly Log
- Laboratory Validation
- PCR
- Plating
- Computerized Time
- Management Systems
- GMP Compliance
- Records Management Systems
- Staff Mentoring
- Regulatory Standards
- Safety Awareness
- Safety Procedures
- Safety Precautions
- Lab Equipment Calibration
- Corrective Action Plans
- Biohazardous Waste Disposal
- High Complexity Testing
- Corrective Actions
Timeline
Business Owner
Three Red Rules LLC
05.2023 - Current
Internal / External Auditor
Self Employed
11.2022 - 05.2023
QC LABORATORY MANAGER / SAFETY MANAGER
Terraboost Media Tazza Brands
07.2021 - 10.2022
QA LAB TECHNICIAN / Food and Safety
Costco
02.2018 - 06.2021
QA LEAD
WeatherTech
08.2017 - 12.2017
MARKETING MANAGER
NRG Home Solar
01.2017 - 06.2017
STORE OPENER|Dollar Tree INC
01.2013 - 10.2016
STORE MANAGER
Dollar Tree Inc
06.2009 - 01.2013
Bachelor of Science - Bachelor of Science in Buisness Administration
Colorado Technical University
Environmental Health And Safety - OSHA Safety Management Training
OSHA
Buisness Management - Certification
Management
Associate of Science - Science, Technology, And Society
Joliet Junior College
Similar Profiles
Dillon LewisDillon Lewis
Lead Programmer / Gameplay Designer at No Rules Make Game LLCLead Programmer / Gameplay Designer at No Rules Make Game LLC
Guy KennettGuy Kennett
CEO and Founder at RED Redstaffing LLC And RED LLCCEO and Founder at RED Redstaffing LLC And RED LLC
Nichole (Nikki) HeldNichole (Nikki) Held
Office Manager at Little Red Nursery LLC / Little Red Landscapes LLCOffice Manager at Little Red Nursery LLC / Little Red Landscapes LLC