Job Description:

Job Description

Responsible for management and control of all daily manufacturing operations, including all staff, budgets, environment and work processes. Ensure compliance with federal, state, ARCBS directives and regional policy and procedures and regulations. Assure compliance with safety policies and procedures in the work area and use of applicable protective equipment at all times to prevent exposure to potentially infectious blood and body fluids. Comply with the Clinical Laboratory Improvement Amendments (CLIA).

* position oversees Components and Quarantine & Labeling not QC or Hospital Services.

Responsibilities:

• Responsible for the management of laboratory staff including, but not limited to, hiring, training, coaching, evaluating and disciplining to ensure a well-qualified team and to enhance operational success and compliance.
• Responsible for management of Manufacturing. Ensure all functions are performed in accordance with all applicable regulatory policies and/or procedures and in a timely manner to meet customer needs.
• Serve as a resource for supervisors for complex technical issues.
• Coordinate the implementation of new or revised tests, procedures, and equipment with SOPs, CFR and OSHA regulations.
• Ensure compliance with state and federal regulations, AABB standards, ARCBS directives and regional policies and procedures.
• Ensure laboratory training and annual competency assessments are completed in compliance with established guidelines in the ARC training system. May act as trainer for department specific curricula.
• Manage and evaluate workflow and processes to ensure efficient and streamlined manufacturing processes to meet customer demand and required timelines.
• Write, organize and maintain technical sections of departmental procedure manual.
• Perform supervisory review of documents.
• Responsible for the accuracy of computer and physical blood component inventories.
• May be responsible for tracking and trending and analysis of laboratory data and the generation of reports.
• Participate in documenting, investigating, troubleshooting and preventing recurrence of department problems, concerns, and complaints.
• Perform other related duties as necessary.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified.

Qualifications

• Bachelor's degree in science, or equivalent related experience; five years' experience including three years management experience.
• Related experience includes laboratory experience with MT (ASCP) certifications or equivalent certifications where required.
• Pharmaceutical manufacturing experience preferred. Good communication and computer skills required. Knowledge of blood products and supplies and the ability to interact with diverse customers is required.
• Must meet state and CLIA requirements Competencies.

The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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