Makeba Isaac-Kristos
Reynoldsburg
Summary
Quality-focused professional with 11+ years of experience in regulated environments spanning pharmaceutical manufacturing and veterinary clinical operations. Specializes in compliance and audit readiness, with demonstrated experience supporting GMP environments and CAPA-driven improvements. Proven ability to maintain adherence to OSHA, DEA, and state regulatory requirements while ensuring documentation accuracy and effective record control, including batch documentation support and clinical logs. Skilled in monitoring quality systems and identifying gaps to reduce deviations and drive continuous improvement.
Overview
2027
2027
years of professional experience
Work History
Senior Manufacturing Process Technician
Amgen
06.2023 - Current
- Authored and revised GMP-compliant SOPs, job aids, and work instructions for manufacturing processes and equipment operation.
- Supported Commissioning and Qualification (C&Q) activities in collaboration with cross-functional teams and external vendors.
- Supported engineering and PPQ (Process Performance Qualification) runs to enable successful transition to commercial manufacturing.
- Create and deliver operator training sessions, incorporating diagrams, photographs, and visual aids to increase comprehension.
- Provided SME-level input during deviations, CAPA investigations, and change control activities related to primary labeling and assembly equipment.
- Operated and troubleshot automated packaging and robotic systems, including Class 3B laser sample identification equipment, utilizing HMI interfaces for system control and monitoring.
- Performed material dispensing, reconciliation, line clearance, and equipment inspections using SAP and electronic batch record systems.
- Assist in initial batch record review to ensure accuracy and regulatory compliance.
- Collaborate with cross-functional teams (Manufacturing, EHS, Engineering) to implement continuous improvement projects that enhance safety, efficiency, and reduce downtime.
- Established area layout and optimize workflow utilizing 5S principles and Lean Six Sigma tools to maximize process efficiency.
- Led line coordination for maintenance and system updates of mobile workstations and handheld devices.
Veterinary Clinical Manager
Red Maples Veterinary Clinic
2018 - 2021
- Built and implemented SOPs and clinical guidelines from the ground up, standardizing workflows and clinical procedures across the practice
- Creation and management of zoonotic, and other communicable infectious disease protocols, significantly reducing staff-related incident occurrences.
- Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
- Contributed to successful accreditation reviews with thorough preparation efforts focused on documentation completeness.
- Managed budgets and allocated resources effectively to ensure sufficient staffing levels and the availability of necessary equipment and supplies.
- Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
- Staff training and improvement; In-clinic liaison for OSHA
training and compliance initiatives - Maintained licensure, including DEA licensure for the purchase
of Class I-IV controlled substances, and radiologic licensure
with the Ohio Department of Health - Performed Class I-IV substance audits; Documented and
assessed for radiation and anesthetic gas exposure levels - Financial risk management based on the current economic
trends that resulted in a 75k revenue increase within the first
year of assuming the role. - Logistic management, including price analysis, and
negotiations of contracts with pharmaceutical representatives
and other service vendors.
Lead Veterinary Technician
Red Maples Veterinary Clinic
2013 - 2021
- Trained and mentored junior technicians on clinical procedures and best practices to enhance team performance.
- Implemented Fear Free standardization protocol to reduced patient stress by providing compassionate handling and improving treatment consistency
- Supervised daily operations of veterinary clinic, ensuring efficient workflow and high-quality patient care.
- Performance and analysis of diagnostic hematologic, fecal, and urinary samples; evaluations of diagnostic imaging. Post-mortem tissue collection and evaluation.
- Intraoperative assistance with a variety of surgeries, including
orthopedic repairs/removals, skin grafts, ophthalmic
repairs/removals, mass removals, as well as female/male
castrations. - Coordinated with external laboratories for prompt and accurate diagnostic test results, aiding veterinarians in determining the best course of treatment.
- Calculated dosages (100% error-free), administered multimodal medications, and dispensed medication and
instructions to clients. - Small animal critical patient medical treatment and
management including anesthetic monitoring, venipuncture,
restorative wound care, and peri/post-operative services. - Prepared surgical instrument packs and drapes for use in sterile environments by processing in autoclave.
- Conducted routine and preventative patient support, as well as educational client counseling.
- Maintained detailed medical records for each patient, across both digital and paper formats,resulting in accurate diagnoses and effective treatment plans.
Education
Associate of Applied Science - Veterinary Technology
Columbus State Community College
Columbus, OHSkills
GMP Compliance & Documentation Control
SOP, Protocol, & Technical Report Authoring
CAPA & Change Control Support
Training Material Development & Delivery
Cross-Functional Team Collaboration
Risk Assessment & Process Troubleshooting
Automated Packaging & Robotic Systems
Quality Assurance Partnership
Process Improvement Initiatives
SAP Transactions & Electronic Batch Records
Timeline
Senior Manufacturing Process Technician
Amgen
06.2023 - Current
Veterinary Clinical Manager
Red Maples Veterinary Clinic
2018 - 2021
Lead Veterinary Technician
Red Maples Veterinary Clinic
2013 - 2021
Associate of Applied Science - Veterinary Technology
Columbus State Community College