Component Laboratory Lead Technician

Blood Bank of Delmarva•Newark, DE

22h•Onsite

About The Position

The Component Laboratory Lead Technician is responsible for manufacturing and providing training and support in the manufacturing of blood products according to cGMP compliant policies and procedures. Ensures that all products meet the safety, purity, and potency requirements of the FDA, AABB, and other regulatory agencies. This position is considered “essential” during severe weather or emergency operation events.

Requirements

High School Diploma or equivalent.
3+ years of related Laboratory or Manufacturing experience or an Associate Degree or higher in Biological Science with post graduate Laboratory experience.
Component production or clinical laboratory experience preferred.
Laboratory manufacturing experience using cGMP experience preferred.
Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

Responsibilities

Prepare and label products routinely according to Component Lab Standard Operating Procedures, including but not limited to red blood cell products, platelets, and plasma products.
Performs visual inspection of blood products at each step of processing as the primary reviewer.
Performs required equipment maintenance, trouble shooting and quality control on assigned instrumentation.
Identify and report problems that may adversely affect products, perform corrections, if applicable, quarantine when required.
Obtain samples for quality control or requested testing from various products as assigned.
Perform testing on samples/products following departmental SOPs to meet standards of regulatory agencies.
Performs general laboratory cleaning, QC, and maintenance.
Monitor inventory of laboratory supplies.
Quarantines products or supplies when required.
Unpack, receive, and inspect shipments containing blood products and/or donor samples.
Respond to environmental and storage alarms. Perform corrective action when necessary.
Performs data entry into BECS and usage of applicable software.
Generates various reports.
Prepare specialty products as defined by department operating procedures.
Execute qualification, validation, and verification protocols.
Identify, investigate, troubleshoot, and perform corrections, if applicable, and quarantine when required for all non-conforming products. Communicate all problems that may adversely affect products to appropriate supervisor/designee.
Manage holds on blood component products, as instructed.
Maintain sufficient reagent stock and other necessary department supplies. Notify the appropriate supervisor/designee when levels are low.
Recognizes and reports to superiors' problems encountered during performance of job tasks including equipment malfunction, deviation from standard operating procedure, unusual results, and discrepancy in test controls or controls outside established normal limits.
Follows laboratory policies and procedures whenever test systems are not within the laboratory’s established performance specifications.
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
Perform competency assessments for non-CLIA activities.
Manage inventory of laboratory supplies and orders as needed.
Investigate product holds and troubleshoot as needed.
Assist in reviewing manufacturing records, as needed.
Perform emergency product release.
Act as a subject matter expert for laboratory equipment.
Makes recommendations to improve business unit practices and processes.
Collaborate on controlled document creation and revision.
Assign tasks to staff members.
Directs day-to-day workflow.
Assign training tasks as needed to staff members.
Train all levels of component staff and others as assigned.
Ensures proper destruction and documentation of final disposition for all non-usable products.
Ensures the department, equipment and all product storage equipment are operational, clean, neat, and well organized.
Prepares shipments of donor samples, as required.
Perform specialized tasks associated with research products as assigned.
Uphold a level of customer service that ensures expectations are met by the end user.
File documentation for the department.
Provide recommendations to improve departmental processes.
Independently performs review of records for product release.
Ensures quality monitoring is complete for blood components and tracks amount tested to meet monthly requirements per regulatory agencies.
Performs any other related duties as assigned.
Obtains continuing education credits offered internally and through industry-related professional organizations to meet state and national regulatory requirements as needed.
On call rotation where applicable.
Perform and review product release as applicable.
Complete Quality Control review steps of all product types selected to be tested for QC before supervisory release.