Lead Technician, Manufacturing Component/Quarantine and Labeling

Manufacture, label and store blood products, manage sample tubes and prepare for shipment, maintain records, perform record reviews and resolve discrepancies. Provide support and leadership guidance to volunteers and line staff and assume operational supervisory responsibilities on designated shift.

Responsibilities

• Manufacture, label and store blood products according to applicable FDA, AABB, CLIA, NRC and Red Cross policies and procedures.
• Manage sample tubes and prepare for shipment.
• Meet the quality and quantity production and distribution goals established by the department.
• Ensure products are suitable for release for distribution and appropriately manage any exceptions.
• Perform good inventory management practices throughout the manufacturing process.
• Prioritize workload of self and others to meet production and customer requirements.
• Operate, maintain and perform validation and quality control checks on equipment.
• Ensure adequate inventory of required supplies.
• Perform data entry and operate the computer programs associated with component production, labeling, storage and sample tube management.
• Maintain accurate, legible and complete manufacturing department records.
• Maintain accurate electronic and physical inventory locations for products/samples.
• Perform supervisory review of manufacturing records.
• Participate in suspect product investigations and problem-solving activities.
• Analyze and make decisions based on visual inspection and information provided from other departments to meet time requirements and quality standards.
• Identify and quarantine products/samples that don’t meet quality requirements.
• Perform disposition of unacceptable products/samples.
• Perform complex manufacturing tasks such as pooled product manufacturing, freeze, wash or deglycerolizing of blood products and pathogen reduction.
• Assume operational supervisory responsibilities on designated shift.
• Participate in training of staff.
• Communicate effectively with internal customers, vendors and volunteers.
• On-call work may be required.

Requirements

• High School or equivalent required, prefer Associates degree.
• Minimum 4 years related experience in a regulatory, laboratory, or manufacturing environment or equivalent combination of education and related experience required.
• Good computer skills, attention to detail, accurate documentation and good decision-making skills.
• Ability to use a wide variety of lab or medical equipment.
• Ability to use a personal computer and applicable software for sustained periods of time.
• Ability to work on a team.
• Good communication skills.

Skills

• Manufacturing Operations
• Regulatory Compliance
• Use of Laboratory Equipment
• Medical Equipment Operation
• Sample Management
• Labeling Procedures
• Shipment Preparation
• Records Keeping
• Documentation Accuracy
• Discrepancy Resolution
• Operational Supervision
• Team Leadership
• Computer Proficiency
• Data Entry

Languages

English