Brazilian Jiu Jitsu
Jackson Jordan
Validation Specialist
Raleigh
Summary
Intelligent and qualified Validation Specialist with extensive experience assessing software systems for alignment with specifications and project goals. Talented at documenting and reporting for accurate recordkeeping. Enthusiastic professional with focus on effectively analyzing test results.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
Work History
Validation Specialist
LMN Services
10.2021 - Current
- Documented entire validation process, noting changes or alterations completed.
- Wrote and executed various documents including specification documents, quality assurance plans, installation and operational qualifications, performance qualifications, retirement plans and summary reports.
- Used Merck's online document writing tool eVal extensively. Expert on generating, writing, testing and reviewing technical documents in the eVal system.
- Generated quality assurance and test plans for aggregation projects, setting specific goals for development and delivery.
- Identified causes of equipment failures and made suggestions for issue resolution.
- Explained highly complex information in terms easily understood by non-technical personnel.
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
- Produced and maintained technical documentation for project reference.
- Drove corrective actions to accomplish project closure and recurrence control.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Managed and inspected instruments and equipment for packaging serialized pharmaceuticals.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
- Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
- Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
- Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
- Enhanced product quality through rigorous testing and data analysis of manufacturing processes.
- Developed comprehensive validation plans, outlining objectives, timelines, and resource requirements for successful project execution.
- Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
- Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
- Improved validation processes by implementing risk-based approaches and streamlining documentation.
- Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
- Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
- Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
- Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
Retention SME
LMN Services
11.2020 - 10.2021
- Logged and maintained GMP documents into retention
- Helped process engineers and other colleagues locate and procure various technical documents
- Identified gaps in retained documents and assisted in bolstering retention process to follow guidelines more properly.
Pre-editor
Bioresources Journal
10.2018 - 01.2020
- Determined readiness of written pieces, made changes, and approved final versions for publication.
- Prepared, rewrote, and edited pieces to improve readability and impact.
- Reviewed articles for grammar, spelling, punctuation, syntax, accuracy, and compliance with quality standards.
- Supported publication by helping develop layouts and collaborating with production teams.
Brand Ambassador
Mediastar Promotions
10.2016 - 07.2018
- Engaged, educated, and befriended customers to deliver amazing shopping experience.
- Showed understanding of customer's personal style and preferences when offering product advice.
- Increased brand awareness through event marketing, demonstrations, sales, and brand promotion.
- Approached strangers and interacted in natural conversation with goal of developing brand loyalty.
Education
Bachelor of Science - Environmental Sciences
NCSU
Raleigh 08.2015 - 12.2019
Skills
Process Analysis
Equipment calibration
Industry standard knowledge
Effective communication
Engineering systems testing
Interpersonal Communication
Problem-Solving
Planning and Coordination
Good Telephone Etiquette
Written Communication
Analytical and Critical Thinking
Process Validation
Validation Protocols
Data Integrity
Interests
Timeline
Validation Specialist
LMN Services
10.2021 - Current
Retention SME
LMN Services
11.2020 - 10.2021
Pre-editor
Bioresources Journal
10.2018 - 01.2020
Brand Ambassador
Mediastar Promotions
10.2016 - 07.2018
Bachelor of Science - Environmental Sciences
NCSU
08.2015 - 12.2019
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