Amber Burns
TN
Summary
Document Control Specialist with 6 years of experience in the pharmaceutical sector, proficient in managing and maintaining controlled documents. Expertise in electronic document management systems, including MasterControl, enhancing workflow efficiency and supporting audit processes. Demonstrated success in collaborating with cross-functional teams to achieve timely approvals and maintain accurate records.
Overview
10
10
years of professional experience
Work History
Document Control Specialist
QuVa Pharma
12.2024 - Current
- Assisted in enhancing the new document control workflow by updating procedures and training other departments on updated processes
- Minimized backlog of Document Change Requests by monitoring statuses and following up with owners, improving workflow efficiency
- Maintained electronic records, ensuring accurate version control and timely approvals.
- Reduced the number of draft documents in MasterControl by ensuring timely review, approval, and follow-up with document owners
- Supported the INFOR 10 reimplementation project through team collaboration, tracking, reviewing, and releasing critical documents to ensure project success
- Supported audits by collaborating with teams, reviewing, and approving documents promptly to ensure compliance and readiness.
- Collaborated with teams to enhance document workflows.
- Implemented tracking system for document management team to streamline workflows.
Lot Disposition Specialist
QuVa Pharma
TX
06.2022 - 12.2024
- Reviewed product and material batch records for compliance with SOPs and regulations.
- Ensured timely release of finished goods and raw materials to meet supply chain demands.
- Participated in cross-functional teams to resolve discrepancies and enhance operational efficiency.
- Maintained accurate disposition logs and supported internal and external audit processes.
- Utilized document management system to organize files, ensuring data accessibility and currency.
Compounding Pharmacy Technician
QuVa Pharma
TX
10.2021 - 06.2022
- Prepared sterile and non-sterile compounded medications following USP guidelines.
- Maintained aseptic cleanroom conditions while documenting batch formulation data.
- Ensured compliance with cGMP, ISO, and OSHA standards.
- Managed equipment calibration and cleanroom sanitation schedules effectively.
- Operated compounding equipment while ensuring cleanliness of workstations.
- Collaborated with team to enhance compounding procedures and operational efficiency.
- Trained new staff on compounding techniques and enforced safety regulations.
- Documented all compounding activities to meet regulatory compliance requirements.
Quality Operations Laboratory Analyst
Eurofins Lancaster Laboratories
Durham, NC
07.2016 - 03.2018
- Conducted virology and safety assays for batch release, including hemadsorption and karyology.
- Maintained Vero and MRC-5 cell lines to ensure experimental integrity.
- Managed inventory and executed equipment troubleshooting to support laboratory functions.
- Trained junior analysts on lab protocols, safety standards, and proper equipment usage.
- Performed laboratory tests on various samples to verify compliance with quality standards.
- Ensured cleanliness and organization of laboratory environment for optimal operations.
- Monitored inventory levels of essential supplies to facilitate uninterrupted laboratory workflow.
- Disposed of laboratory materials following established guidelines to maintain safety standards.
Biologist (Contract)
Joule Scientific
Durham, NC
04.2016 - 07.2016
- Conducted virology testing to support batch release.
- Implemented lean lab practices to reduce waste and optimize workflow.
- Entered and tracked results in laboratory information management systems (LIMS).
Education
Bachelor of Science - Biology
The University of North Carolina at Pembroke
Pembroke, NC01.2015
Skills
- Document management and archiving
- Process optimization and improvement
- Cross-functional collaboration
- Team training and support
- Effective communication
- Attention to detail
- Problem solving
- Time management
- Adaptability and flexibility
- Data accuracy and management
Timeline
Document Control Specialist
QuVa Pharma
12.2024 - Current
Lot Disposition Specialist
QuVa Pharma
06.2022 - 12.2024
Compounding Pharmacy Technician
QuVa Pharma
10.2021 - 06.2022
Quality Operations Laboratory Analyst
Eurofins Lancaster Laboratories
07.2016 - 03.2018
Biologist (Contract)
Joule Scientific
04.2016 - 07.2016
Bachelor of Science - Biology
The University of North Carolina at Pembroke