Operational Support Analyst- Testing & Blood Manufacturing

POSITION SUMMARY

Under the direction of the department Manager, provides support to Blood Services operational departments to achieve process control, continuous improvement, customer satisfaction, and overall operational effectiveness/quality with respect to compliance with regulations, safety, and quality measurements of operations.

DUTIES AND RESPONSIBILITIES

• Works with departmental staff/management to review departmental SOPs for correctness, ease of use and compliance with regulations, policies, and pertinent quality performance standards and expectations.
• Assists with impact assessments, process analysis and supports change management.
• Consults with operational units to oversee efficient change control and validation processes.
• Works directly with the operational units to collect, organize, monitor, and distribute information related to the quality functions within the departments.
• Oversees and assists departments with tracking audits, proficiency testing results, and incident management documentation. Makes recommendations for improvements, corrective or preventative actions and responses to audits/surveys.
• Prepares monthly reports.
• Determines product suitability resulting from incident management events.
• Monitors the effectiveness of changes and corrective actions; coordinates follow-up and participates in system design and implementation to ensure process control.
• Serves as a resource person for procedural and regulatory issues for the department.
• Participates in external and internal audits.
• Supports lot release functions and reviews operational records on a daily, monthly, and quarterly basis as needed.
• Leads projects for organizational/department changes at a local level.
• Using Versiti core values, works toward achievement of departmental goals and objectives in support of Versiti’s vision and mission.
• Maintains up-to-date knowledge of quality issues through participation in meetings, task forces, committees and self-directed learning.
• Upholds and reinforces the customer service standards of Versiti.
• Participates in creation and delivery of training on a process level.
• Acts as a partner with the other members of the departments to provide services to customers.
• Performs other duties as assigned.

QUALIFICATIONS

Education

• High school diploma or equivalent required.
• Bachelor’s degree in science or field related to blood center activities preferred.

Experience

• Two years technical or consultant experience in a regulated industry where change management, validation and creation of SOPs (standard operation procedures) have been required.
• Manufacturing experience in a cGMP, ISO (International Organization for Standardization), or equivalent certified environment is preferred.

Skills and Knowledge

• Strong organizational skills with excellent verbal and written communication skills
• Ability to functionally apply federal, state, and accrediting agency regulations to departmental processes.
• Proven ability to recognize and enforce compliance to SOPs (standard operating procedures)
• Strong facilitation skills
• Capability to learn, apply and facilitate root cause analysis
• Strong critical thinking and problem-solving skills
• Skilled in coaching to improve performance and achieve departmental goals
• Ability to write technical information in a clear and concise manner
• Working knowledge of quality business processes such as current Good Manufacturing Practices (cGMPs) and Continuous Improvement (CI)
• All New Employees must be fully vaccinated for COVID-19 with first dose administered no more than 15 days after hire date.

Tools and Technology

• Personal Computer (desk top, lap top, tablet)
• General office equipment (computer, printer, fax, copy machine)
• Computer software including word processing, spreadsheets, databases, statistical analysis tools