Job Information
OctaPharma Plasma Quality Systems Data Manager in Charlotte, North Carolina
Description
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Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:
Quality Systems Data Manager, Charlotte, NC
This Is What You’ll Do:
System Administration:
Manage and maintain the Quality Management System (QMS) application, ensuring its availability, and performance.
Lead the configuration of the QMS software to meet business needs, including setting up workflows, user permissions, document templates, and quality processes.
Provide technical support and training content for end users.
Troubleshoot QMS to resolve technical issues.
Coordinate and implement software updates and upgrades in collaboration with the Business Applications and IT departments.
Data Analysis and Reporting:
Collaborate with the Data Analytics department to analyze data from various sources, including collection centers, laboratory results, and quality control systems, to identify trends, anomalies, and areas for improvement.
Develop and maintain dashboards, reports, and data visualizations to communicate findings to stakeholders.
Ensure accuracy, integrity, and completeness of data used for quality assurance purposes.
Quality Assurance Monitoring:
Monitor key quality metrics related to plasma collection and processing, ensuring compliance with FDA regulations and company standards.
Perform root cause analysis on quality incidents and deviations and recommend corrective and preventive actions (CAPA).
Assist in the development and validation of quality assurance data.
Regulatory Compliance:
Support the preparation of regulatory submissions and audits by providing accurate and timely data.
Ensure that all data-related activities comply with FDA regulations, cGMP guidelines, and internal policies.
Maintain documentation and records as required by regulatory agencies.
Process Improvement:
Identify opportunities for process optimization and efficiency improvements within the quality assurance framework.
Collaborate with cross-functional teams to implement data-driven solutions that enhance product quality and safety.
Participate in continuous improvement initiatives and contribute to the development of best practices.
Collaboration and Communication:
Work closely with quality assurance, operations, regulatory affairs, and IT teams to support data-related projects and initiatives.
Communicate findings, risks, and recommendations to management and other stakeholders in a clear and concise manner.
Provide training and support to team members on data analysis tools and techniques.
This Is What It Takes:
Bachelor’s degree in data science, Statistics, Computer Science, or a related field required.
Minimum of 2-4 years of experience in data analysis or administering software applications, preferably in a quality management environment.
Proficiency in data analysis tools (e.g., Excel) and data visualization software (e.g., Tableau, Power BI). Experience with statistical analysis and quality control methodologies (e.g., Lean Six Sigma) is preferred.
Familiarity with cGMP guidelines for the management of a QMS application required.
Strong problem-solving abilities with attention to detail and a passion for data-driven decision-making required.
Excellent verbal and written communication skills with the ability to convey complex information to both technical and non-technical audiences required.
Ability to work effectively in a collaborative, cross-functional team environment.
Do Satisfying Work. Earn Real Rewards and Benefits.
We’re widely known and respected for our benefits and for leadership that is supportive and hands-on.
Formal training
Outstanding plans for medical, dental, and vision insurance
Health savings account (HSA)
Employee assistance program (EAP)
Wellness program
401 (k) retirement plan
Paid time off
Company-paid holidays
Personal time
More About Octapharma Plasma, Inc.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.
INNER SATISFACTION.
OUTSTANDING IMPACT.