The incumbent will be responsible for the day-to-day execution of our quality program, including managing the Quality Management System, facilitating discrepancy investigations and root cause analysis, identifying options for corrective and preventative actions, reviewing process documentation for consistency and as training resource, and helping to create and troubleshoot automated workflows.
Key Deliverables:
QMS management
Discrepancy investigation
CAPA management
Quality Metrics
Specific Duties/Responsibilities:
Play a leadership role in getting staff to work collaboratively with the ultimate goal of improving and documenting business processes through the discrepancy process, ensuring that discrepancies are resolved in a timely manner.
Participate in teams and initiatives that identify and eliminate internal processes’ limitations and inefficiencies.
Work closely with the compliance team to ensure that process changes are adequately reflected in SOPs and adhere to compliance requirements.
Work with department leads and key users to develop appropriate training curricula and training materials. Review and suggest modifications as needed to process and training documentation.
Utilize selected Lean, Six Sigma, or other techniques to improve quality and efficiency throughout the organization. Facilitate and lead root cause analysis.
Implement and monitor quality measures that measure performance and drive continuous improvement to achieve business excellence.
Continue to expand the quality program at Direct Relief.
Create and maintain automated workflows related to the QMS using tools like Microsoft’s Power Automate.
Skills, Attributes, and Qualifications:
Skills:
Proficient in working with Microsoft Word, Excel, Visio, SharePoint, and Power Automate.
General knowledge of quality systems, ERP systems (SAP preferred), computer-based management systems, ISO standards, and application of FDA regulations for applicable products preferred.
Strong data analysis, data management, and quantitative skills.
Knowledge of Lean and Six Sigma principles and experience using those tools in improvement activities preferred.
Attributes:
Must have a collaborative work style.
Must possess strong analytical and problem-solving skills.
Must be a team player with strong verbal and written communication skills.
Must have a commitment to high standards of professionalism and integrity.
Must be patient and work with users to help them understand and learn concepts at a pace that matches individual skills.
Ability to work independently with minimum supervision.
Detail oriented with the ability to take initiative and work independently.
Qualifications:
Knowledge of and experience with Supply Chain Management, Warehousing, Distribution, and Logistics in an FDA-regulated industry required with a sound understanding of GDP.
Solid working experience in a position related to Quality Management Systems, including good understanding of requirements for documentation and training management in GxP environment.
Good working business process knowledge of procurement, operations, warehousing, and order fulfillment.
Bachelor’s Degree
3+ Years of related experience.
Team members of Direct Relief enjoy a complete and generous benefit package including company paid health, dental, vision, and life insurance, holidays, sponsored gym membership, 401k programs, paid Maternity and Paternity leave, and state of the art facility.
Direct Relief, a humanitarian aid organization, active in more than 100 countries and all 50 US states and territories, is improving the health and lives of people affected by poverty and/or emergencies. Direct Relief has built its reputation over 70 years, consistently earning top recognition from independent charity evaluators. We are the 3rd largest US charity and Forbes recently ranked Direct Relief #5 in their top 100 Charities. Charity Navigator awarded Direct Relief a perfect score of 100. Direct Relief’s vision is to be the world’s leading, most transparent, and most efficient provider of charitable medical resources to people most in need of assistance. Direct Relief is a nongovernmental, nonsectarian, and not-for-profit provider to people and communities regardless of politics, religious beliefs, ethnic identity or ability to pay.
