Quality Specialist

About us:

Direct Relief is a medical aid nonprofit, active in all 50 states and more than 80 countries, with a mission to improve the health and lives of people affected by poverty or emergencies – without regard to politics, religion, or ability to pay.

Since its founding in 1948 by refugees of WWII, Direct Relief has grown to become one of the country's most effective humanitarian assistance organizations. Its work earns broad recognition from independent charity rating agencies, including a 100% fundraising efficiency rating from Forbes, a top ranking by Charity Navigator, and a spot in Fast Company’s list of “the world’s most innovative nonprofits.” Direct Relief’s impact throughout the world is the result of its dedicated and compassionate people, each of whom plays a critical role in advancing the organization's mission.

Summary:

The Quality Specialist will support the day-to-day execution of our quality program, including managing the Quality Management System, facilitating discrepancy investigations and identifying options for corrective and preventative actions, reviewing process documentation for consistency and as training resource, and helping to create and troubleshoot electronic workflows. This role is onsite in Santa Barbara, CA.

Key Deliverables:

• Discrepancy investigation
• CAPA management
• Training resources
• Published documents

Specific Duties/Responsibilities:

• Lead discrepancy investigations, including root cause assignment, CAPA creation, and CAPA completion timelines.
• Support quality program initiatives across administrative functions, including process development and continuous improvement initiatives.
• Participate in teams’ initiatives that identify and eliminate internal process limitations and inefficiencies.
• Support the management of the electronic Quality Management System, including workflow development, and staff training.
• Collaborate with teams to develop effective training programs, including training documents, effectiveness checks, and other best practices.
• Support the growth and management of the supplier approval program.
• Develop, implement, and monitor product quality initiatives as part of the supplier approval program.
• Support and participate in supplier audits, including 3PL site visits.

Skills, Attributes, and Qualifications:

Skills:

• Proficient in working with Microsoft Word, Excel, Visio, PowerPoint and SharePoint.
• General knowledge of electronic quality systems (MasterControl preferred), 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.
• Knowledge of best practices for employee training programs.

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.

We appreciate your interest in employment with Direct Relief. Direct Relief is committed to creating a diverse environment and is proud to be an equal opportunity employer. We welcome all applicants regardless of race, color, religion, creed, national origin, ancestry, sex, gender, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, gender expression, marital status, or any other legally recognized protected basis under federal, state, or local law to apply and be part of our growing team.

Must have US work authorization to be considered for role. Sponsorship not available.