Under minimal direction, this position serves as the technical subject matter expert and is responsible for the technical oversight of laboratory services. Ensures Current Good Manufacturing Practice (cGMP) regulations are in place for the manufacturing processes including SOPs, training and competency, and error management.
DUTIES AND RESPONSIBILITIES:
- Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
- Assures quality customer service to all customers.
- Maintains good attendance and punctuality per the absence policy.
- Hires, supervises, trains, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.
- Oversees technical processes to assure compliance with laboratory SOPs and regulations; oversees the laboratory and assigned departments work flow.
- Ensures the accuracy, completeness, timeliness, and document control of testing records. May prepare and/or review laboratory reports and records in accordance with SOPs. Takes corrective action and documents incidents. May perform final review of high-complexity testing records per CLIA requirements.
- Writes Internal Procedures, as appropriate.
- Performs pilot studies, as assigned.
- Manages the reporting and resolution of deviations (e.g., errors, quarantine, recall, equipment/reagent failures, and accidents). Oversees technical support services such as Post Donation Information, and Progesa Corrections.
- Develops and maintains regular and effective communications and relations with hospital personnel. Customer relationship is proactive and on-going and may include problem-solving, education, technical support, and program development.
- Assists District Director of Manufacturing and Laboratory Services with donor notification, donor counseling, and look back.
- Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree required.
- Certification as a Medical Technologist by a recognized certifying agency required.
- Certification as a technologist in blood banking (BB) or specialist in blood banking (SBB) preferred.
- State licensure (as required by regulations).
- Five years laboratory experience required. To include:
- Three years supervisory experience required.
- Previous blood bank or blood center experience preferred.
- Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
- Must be able to maintain confidentiality.
- Ability to work in a team environment and participate as an active member of management.
- Effective oral and written communication skills.
- Must have a participative management style, strong team development, and coaching skills.
- Must have analytical, statistical, personal organization, and problem solving skills.
- Must have proficient computer skills.