Briah Long
Bloomsburg,PA
Summary
Highly motivated and hardworking Quality Assurance Specialist with over 5 years of experience in the pharmaceutical industry. Excellent reputation for resolving problems and driving regulatory compliance initiatives. Extensive knowledge of FDA, GMP/cGMP (21 CFR 11, 210, 211), ICH, and GLP requirements.
Overview
8
8
years of professional experience
Work History
Senior GMP Quality Assurance Specialist
Product Safety Labs
03.2022 - 12.2022
- Collaborated with management to implement a cGMP quality program on site.
- Educated employees on cGMP quality standards and assisted with creation and maintenance of quality training.
- Developed and implemented equipment validation program for the facility and provided guidance to system owners to identify and resolve compliance gaps.
- Authored and reviewed technical documents such as SOPs, validation test plans, and training materials to support cGMP program development.
- Developed and implemented performance improvement strategies and plans to promote continuous improvement
Quality Assurance Analyst
Troy Manufacturing, Inc.
03.2017 - 03.2022
- Appointed lead SME of company's analytical laboratory.
- Revised and implemented a validation program on site to ensure regulatory compliance of equipment and laboratory testing methods.
- Developed and maintained on-site stability study program for finished drug products.
- Conducted CAPA/root cause investigations and participated in internal audits of the facility.
- Authored and reviewed technical documents such as SOPs, validation protocols, training materials, deviation reports and trend analyses.
- Monitored process checks for proper completion and correct frequency.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
Deli Sales Associate
Giant Food Stores
03.2015 - 06.2017
- Greeted customers at counter to fulfill requests and answer questions.
- Maintained clean, trash-free workspaces to maximize productivity and safety.
- Cleaned and sanitized dishes and utensils, consistently keeping adequate supplies on hand for expected customer loads.
- Responded to telephone inquiries regarding available products and services and helped customers make appropriate choices.
- Restocked supplies and prepared additional ingredients during downtime for expected busy periods.
Education
No Degree - Chemistry
Bloomsburg University of Pennsylvania
Bloomsburg, PAHigh School Diploma -
Columbia County Christian School
Bloomsburg, PA06.2014
Skills
- Data Analysis
- CGMP Compliance
- Site Auditing
- Batch Record Review
- Project Management
- Adaptability and Flexibility
- Vendor Relations
- Technical Liaising and Consulting
- Technical Writing
- Documentation
- Microsoft Office Programs (Word, Excel, PowerPoint, Office, Teams)
- GMP Standards
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Senior GMP Quality Assurance Specialist
Product Safety Labs
03.2022 - 12.2022
Quality Assurance Analyst
Troy Manufacturing, Inc.
03.2017 - 03.2022
Deli Sales Associate
Giant Food Stores
03.2015 - 06.2017
No Degree - Chemistry
Bloomsburg University of Pennsylvania
High School Diploma -
Columbia County Christian School
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