Ebony Collins
Clayton
Summary
Experienced in fast-paced environments and adaptable to last-minute changes. Thrives under pressure and consistently earns high marks for work quality and speed.
Overview
11
11
years of professional experience
Work History
Supervisor - Deviation Writer
Fresenius Kabi
Wilson, North Carolina
04.2024 - Current
- Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements
- Write concise and accurate investigation reports
- Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence
- Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process
- Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs
- Initiate Change Controls as required for Manufacturing and Packaging operations
- Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices
- Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities
- Perform other related assignments and duties as required and assigned
- Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching
- While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting
Lead - Quality Assurance Floor Support Specialist
Eli Lilly
Durham, North Carolina
04.2022 - 04.2024
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- Provides daily presence in operational areas to: monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
- Monitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete
- Supports visual inspection AQL inspection
- Review and approve GMP documentation in support of daily operations such as: Initiate and investigate deviations and observations
- Redline and approve SOPs and procedures, job plans
- Daily documentation of quality on the floor oversight. Daily checks for ALCOA+ and data integrity
- Assures proper documentation via electronic batch records, logbooks, etc.
- Return to Service and Release of equipment, product, and area HOLDs
- Work Order assessments and issue resolution
- Provide guidance and assistance in identifying potential product quality impact and assessing if observations are required
- Provide QA systems support to reconcile issues in multiple systems such as: SAP (inventory management)
- Assist in internal and external audits
- Participate in risk assessments, root cause analysis, CAPAs, change controls
- Veeva (controlled document repository)
- GMARS (calibration and maintenance system)
- Work within teams to ensure all manufacturing areas receive QA support needed to maintain daily operations and train new employees
- Reviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions)
Quality Assurance Specialist
Pfizer
Rocky Mount, NC
04.2015 - 04.2022
- Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs.
- Experience with SmartSheet, VeevaVault, LIMS, PMX, Trackwise
- Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
- Batch record review
- CAPA; Deviation investigation, Change Control approved
- SOP redline and technical writer
- Participates in rapid response and provides quality guidance for deviation events
- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
- Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
- Performs real time quality batch record review
Education
Associate of Science - Chemistry
Southern New Hampshire University
High School Diploma -
Rocky Mount High School
Skills
- Quality assurance
- Technical writing
- Root cause analysis
- Regulatory compliance
- Documentation management
- Problem solving
- Effective communication
- Team collaboration
Education and Training
High School Diploma
Associate of Science
Timeline
Supervisor - Deviation Writer
Fresenius Kabi
04.2024 - Current
Lead - Quality Assurance Floor Support Specialist
Eli Lilly
04.2022 - 04.2024
Quality Assurance Specialist
Pfizer
04.2015 - 04.2022
High School Diploma -
Rocky Mount High School
Associate of Science - Chemistry
Southern New Hampshire University