Doris Eziefula
Owings Mills
Summary
Results-driven Biotechnology Professional with extensive experience in cGMP-compliant manufacturing environments. Expertise in completing Batch Production Records, managing deviation investigations, and leading CAPA processes to ensure regulatory compliance and product quality. Adept at troubleshooting equipment issues, developing creative operational solutions, and optimizing manufacturing processes. A qualified trainer of all manufacturing processes, with strong cross-functional collaboration skills and a focus on continuous improvement.
Overview
9
9
years of professional experience
Work History
Manufacturing Associate II
Catalent Pharma Solutions
10.2023 - Current
- Exceeded daily production targets with consistent attention to detail and commitment to meeting deadlines.
- Participate in risk assessments and CAPA (Corrective and Preventive Actions) related to batch record discrepancies
- Maintained accurate production records for analysis purposes, ensuring traceability of products throughout the entire manufacturing process.
- Met tight deadlines through effective time management skills prioritizing tasks based on their importance related overall success operation.
- Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals.
- Increased team productivity by providing ongoing training, guidance, and support to fellow associates.
- Ensure timely production and quality of products in cGMP-compliant manufacturing environments
- Conduct detailed reviews of Batch Production Records (BPRs) for completeness, accuracy, and compliance with GMP, SOPs, and regulatory requirements
- Ensure all discrepancies, deviations, and non-conformances are properly documented, investigated, and resolved before batch release
- Collaborate with manufacturing, quality control, and other departments to ensure batch records meet all quality and compliance standards
- Assist in the development and implementation of quality assurance processes and procedures to improve batch record accuracy and completeness
- Support internal audits and regulatory inspections by providing necessary documentation and responses related to batch record reviews
- Stay current with industry regulations, guidelines, and best practices in the pharmaceutical and biotech industries, ensuring all activities comply with FDA, EMA, and other relevant regulatory agency requirements.
Manufacturing Associate I
Catalent
05.2022 - Current
- Qualified trainer of all upstream manufacturing processes, providing training to new and current staff on best practices and compliance.
- Ensure that products were produced on time and are of good quality.
- Performs batch record review and logbook review
- Examine incoming materials and compared to documentation for accuracy and quality.
- Organize work to meet demanding production goals.
- Performs and documented cGMP activities to support upstream production areas and operations
- Documents/Record cGMP data and information for processing steps and/or equipment activities, following standard operating procedures
- Operates bench top equipment including pH, pumps, tubing welders, filter integrity testers
- Maintains equipment, area, and cleaning logbooks
- Actively participates in training activities, managing their individual training plan
- Submits in-process and cleaning samples to Quality Control with required documentation
- Troubleshoot process and equipment problems, work with facilities and validation to maintain manufacturing equipment
- Examined incoming materials and compared to documentation for accuracy and quality.
- Completes batch production records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing
Pharmacy Technician
CVS
05.2018 - 01.2020
- Answered incoming phone calls and addressed questions from customers and healthcare providers.
- Calculated dosage, filled prescriptions and prepared prescription labels with absolute accuracy.
- Counted and labeled prescriptions with correct item and quantity.
- Stocked, labeled and inventoried medication to keep accurate records.
- Maintained proper drug storage procedures, registries, and records for controlled drugs.
- Collected co-payments or full payments from customers.
- Solved customer problems in-person or over telephone by providing assistance with placing orders, navigating systems and locating items.
- Consulted with insurance company representatives to complete claims processing, resolve concerns and reconcile payments.
- Restocked pharmacy shelves with current merchandise to drive consistent peripheral sales.
- Helped pharmacist clear problematic prescriptions and address customer questions to keep pharmacy efficient.
- Reviewed and verified customer information and insurance provider information.
- Performed various pharmacy operational activities with strong commitment to accuracy, efficiency and service quality.
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.
Undergraduate Student Researcher
NIH/ASCEND
06.2015 - 05.2017
- Conducted research on "Identifying Sources of Stress Among First Generation Traditional College Students in an Historically Black College or University (HBCU)."
- Performed routine data analysis to correct and verify data entry.
- Interpreted and analyzed research data to draw conclusions on outcomes.
- Assisted with writing and editing experimental results for publication in journals.
- Attended meetings and presentations to learn more details about public health/behavioral science.
- Conducted research for proposals and assessed potential impact on constituents.
- Used SPSS to prepare and manipulate extensive databases.
Education
Bachelor of Science - Biology
Morgan State University
Baltimore, MDMaster of Science - Biotechnology
John Hopkins University
Baltimore, MDSkills
- Aseptic techniques
- CAPA Management
- Critical Thinking
- Data Entry
- Good Manufacturing Practices
- Good Documentation Practices
- Supporting Cell Culture techniques
- Strong MS Word/Excel/Powerpoint Proficiency
Timeline
Manufacturing Associate II
Catalent Pharma Solutions
10.2023 - Current
Manufacturing Associate I
Catalent
05.2022 - Current
Pharmacy Technician
CVS
05.2018 - 01.2020
Undergraduate Student Researcher
NIH/ASCEND
06.2015 - 05.2017
Bachelor of Science - Biology
Morgan State University
Master of Science - Biotechnology
John Hopkins University
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