Avery Wilson
Baltimore,Maryland
Summary
Professional in quality assurance with over 4 years of production experience. A specialist in production focused quality with insight into, manufacturing operations, quality systems, risk analysis and conflict management. Possesses problem-solving, interpersonal, and leadership skills to build effective interactions with work teams and consumers.
Overview
5
5
years of professional experience
Work History
Senior Biopharmaceutical Associate
GlaxoSmithKline
Rockville, Maryland
04.2021 - Current
- Collaborated in Cross department problem solving GEMBAs and RCAs to reduce recurring deviations
- Inspected, verified and documented quantifiable characteristics of material goods comparing against batch records and SAP(mERP) data
- Collaborated with Validation to re-qualify Steam in place cycles improving equipment turnaround time roughly 30%
- Lead quality and compliance driven initiatives to improve efficiency of batch record review and turnaround time within production
- Revamp and implementation of materials management monitoring report system using SAP resulting in 15% increase in accuracy per report
- Coordinated operations of a production team of 8 via task delegation. Ensuring both process requirements and quality standards are met
- Creation and revision of Standard operating procedures and training plans in VEEVA and QUMAS within regulatory standards
Biopharmaceutical Associate II
GlaxoSmithKline
Rockville, Maryland
12.2019 - 04.2021
- Verification and closure of batch records to ensure timely release of BDS (bulk drug substance)
- Creation and recordation of Deviations and out of specification batch record comments(OOBR) with collaboration from operational quality
- Reviewed documentation such as batch records and logbooks for accuracy, completeness and adherence to cGMP
- Coordinated change over and area walkthrough/release operations
- Implementation and decommissioning of GMP equipment
- Conducted routine inspections and test of production equipment and assemblies for correct operation and compliance to performance specifications
- Managed daily operations of the production environment, including task delegation and cross department communications
Biopharmaceutical Associate I
GlaxoSmithKline
Rockville, MD
01.2019 - 12.2019
- Creation and implementation of cleaning verification and clean validation schedule for production equipment
- Lead EHS (Environmental, Health and Safety) projects/activities designed to eliminate hazards and improve overall safety standards of production environment
- Conducted monthly self inspection of cCMP area to maintain quality standard and inspection readiness in preparation of external audits
- Per maintenance on production equipment such as Vi-Cell viability analyzer, YSI biochemistry analyzer, RAPIDLab 1200 Systems.
Education
Bachelor of Science - Biology
Salisbury University
05.2018
Skills
- Root Cause analysis (RCA)
- GEMBA
- SixSigma 5S
- Documentation/Batch Recorded reviews
- Good Manufacturing Practices(cGMPs)
- Good Documentation Practices(cGDPs)
- Analytical research
- Chemical Handling
- Data analysis
- Data Entry
- Microsoft Office
- Specification testing
- Time management/Multi-Tasking
- SAP enterprise resources planning (ERP) software
- VEEVA Quality management system
- QUMAS Quality management system
- SYNCADE Manufacturing execution system (MES)
- DeltaV
- DARTS
- WEBSTATISTICA
Timeline
Senior Biopharmaceutical Associate
GlaxoSmithKline
04.2021 - Current
Biopharmaceutical Associate II
GlaxoSmithKline
12.2019 - 04.2021
Biopharmaceutical Associate I
GlaxoSmithKline
01.2019 - 12.2019
Bachelor of Science - Biology
Salisbury University