KYRA SKINNER
Houston,TX
Summary
Quality Operations leader with 10+ years of progressive experience spanning pharmaceutical, manufacturing, quality assurance, investigations, environmental monitoring, and batch disposition. Experienced in leading high-performing teams, driving quality system improvements, and delivering operational results within a fast-paced 503B pharmaceutical environment. Combines strong technical expertise with strategic leadership to improve compliance, strengthen quality systems, and support organizational growth.
Overview
12
12
years of professional experience
Work History
Manager, Quality Operations
Empower Pharmacy
Houston, Texas
09.2024 - Current
- Lead Quality Operations and Environmental Monitoring programs supporting aseptic filling and finishing operations, ensuring compliance with cGMP, FDA, and USP requirements.
- Manage Quality Operations and Environmental Monitoring personnel, providing oversight, coaching, training, and performance management to support quality and compliance objectives.
- Oversee environmental monitoring investigations, excursions, trend analysis, and corrective actions to maintain state of control within classified manufacturing areas.
- Direct investigations, deviations, complaints, CAPAs, and manufacturing excursions, ensuring timely closure and regulatory compliance.
- Establish and lead cross-functional review boards for Change Controls, Investigations, Complaints, CAPAs, and Environmental Monitoring events to improve compliance and operational performance.
- Drive quality system remediation and continuous improvement initiatives, resulting in significant reductions in backlog volume and improved quality metrics.
- Serve as the quality subject matter expert for aseptic processing, sterility assurance, environmental monitoring, and quality system compliance.
Supervisor, Quality Assurance
Empower Pharmacy
Houston, Texas
12.2022 - 09.2024
- Currently serving as a Quality Assurance Supervisor at Empower Pharmacy, overseeing and managing quality assurance activities to ensure compliance with regulatory standards and internal quality management systems. I am responsible for leading a team of quality assurance specialists and coordinating with other departments to maintain high standards of product quality and safety.
- Lead and manage the quality assurance team, providing guidance and support to ensure compliance with regulatory standards and company policies.
- Develop and implement quality assurance processes and procedures to optimize product quality and safety.
- Approves or rejects all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
- Prepare and maintain quality documentation and records, ensuring accuracy and completeness for regulatory compliance.
Quality Assurance Specialist
Empower Pharmacy
05.2021 - 12.2022
- Served as a Quality Assurance Specialist at Empower Pharmacy, where I was responsible for ensuring the quality and compliance of products and processes. I implemented corrective actions to improve overall quality. Additionally, I maintained quality management systems and documentation, and collaborated with cross-functional teams to ensure adherence to quality standards.
- Follows all regulatory, cGMP and USP guidelines as required by job function.
- Ensures all work is performed and documented promptly, according to approved SOP and in general compliance with cGMP.
- Performed and reviewed routine manufacturing, environmental monitoring and QC data for in-process and finished products.
- Identified potential quality issues in production processes and reported them to management.
- Analyzed quality and performance data to support operational decision-making.
- Addressed non-conformance issues and participated in corrective actions.
Manufacturing Quality Assurance Specialist
Fresenius Kabi
01.2017 - 05.2021
- Worked as a Manufacturing Quality Assurance Specialist at Fresenius Kabi, where I ensured that all documentation aligns with good manufacturing practices, and that our manufacturing processes were executed flawlessly.
- Provided guidance to personnel involved in the manufacturing process as needed.
- Verified critical steps in the manufacturing process, including component lot numbers, expiration dates, weight/volume, mixing, etc.
- Established and maintained a comprehensive database of quality data and metrics for analysis and reporting.
- Developed and implemented quality control processes to ensure product safety and reliability.
Packaging Operator
Fresenius Kabi
12.2014 - 01.2017
- Worked as a Packaging Operator at Fresenius Kabi, where I was responsible for the full set and safe, clean, efficient and consistent operation of inspection and packaging equipment and all associated documentation.
- Maintained "Zero Defect" focus for all controllable packaging related quality measures, including AQL's, line clearances, documentation and re-inspections.
- Takes full responsibility of quality, personnel and productivity of packaging lines with HMI applications.
- Makes machine adjustments when necessary and determines when maintenance support is required.
- Assures strict adherence to SOP's and cGMP's coordinates all line activities including segregation and re-inspections.
Visual Inspector
Fresenius Kabi
09.2014 - 12.2014
- Worked as a visual inspector for Fresenius Kabi, where I visually inspected filled products off the filling lines following standard operating procedures and current good manufacturing processes.
- Visually inspected products for various defects.
- Sets-up, adjust, and operators equipment such as inspection machines.
- Calculates percent defective on inspection results and reconciles components on batch records.
Education
GED -
General Educational Development (GED), New York
Skills
- Quality Operations Leadership
- Strategic Quality Planning
- Inspection Management (FDA, State Board, Customer Audits)
- Sterile Manufacturing Oversight
- Quality Culture Development
- Operational Excellence
- KPI Development & Performance Management
- Resource Planning & Team Development
Timeline
Manager, Quality Operations
Empower Pharmacy
09.2024 - Current
Supervisor, Quality Assurance
Empower Pharmacy
12.2022 - 09.2024
Quality Assurance Specialist
Empower Pharmacy
05.2021 - 12.2022
Manufacturing Quality Assurance Specialist
Fresenius Kabi
01.2017 - 05.2021
Packaging Operator
Fresenius Kabi
12.2014 - 01.2017
Visual Inspector
Fresenius Kabi
09.2014 - 12.2014
GED -
General Educational Development (GED), New York