The Laboratory Technician II will be responsible for performing laboratory testing, recording of results as well the manufacturing and labeling of blood products.
General Laboratory Essential Responsabilities
Manufacture and process blood products by following Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMP’s)
Assist in revision and creation of SOPs
Operate hematology analyzer and perform pH testing
Perform quality control and preventative maintenance on laboratory equipment as assigned. Maintain records in compliance with manufacturing and regulatory guidelines
Prepare, pack, and send out samples from blood collections for testing
Prepare and pack blood products for distribution to customers
Label blood products, including assigning labels and recording information
Identify and troubleshoot problems encountered in assigned tasks and properly document corrective actions. Confer with supervisor for resolution of problems
Ability to identify and aid in the investigation of deviations
Able to read, interpret, and understand company and industry manuals and compliance standards such as Standard Operation Procedure manuals, Current Good Manufacturing Practices, FDA, UE, and AABB regulations
Perform environmental monitoring as well as read and record the results
Knows and follows safety rules relative to area(s) or responsibility. Follows Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and external regulations regarding the products and procedures
Present a professional image to HemaCare customers, internal and external
Will be the lead trainer as well as coordinate training with the Laboratory Director for all lab technician functions
Aid in the equipment maintenance and validation program for General Lab
Aid in the process development of GMP procedures that will be performed within the cleanroom with the assistance of the Senior Clinical Scientific Laboratory Directo
Cleanroom Essential Responsibilities
Personnel will properly gown into a Class A and Class B environment
Aseptic production of primary human cells within the cleanroom suite using accompanying documentation according to GMP guideline
Maintenance, cleaning, calibrating, and qualification of cleanroom equipment as required
Maintenance and cleaning of cGMP/clean room areas
Select personnel will be responsible for the maintenance of released materials for inventory control.
Inventory maintenance of gowning and cleaning supplies within the cleanroom suite
Select personnel will be responsible for the maintenance of the manufacturing kit maintenance – Preparation of the kits for use within the clean room to be reviewed by Quality Assurance personnel.
Aid in the coordination of Media Fills and gowning qualifications
Quality Control Testing Responsibilities
Review and perform the removal of expired materials from the laboratory
Environmental monitoring of the cleanroom suite
Viable Surface Monitoring
Coordinate and perform environmental monitoring in the Cell Processing and General Lab as well as read and record the results
Some coordination for reading the data from EM plates in conjunction with the Laboratory Director
Initiate deviations and perform investigations of Environmental Monitoring excursions
Trend and analyze EM data as it pertains to facility integrity
Maintain and author specification documentation for materials within the General Lab, QC, and cleanroom areas.
Identify alternative vendors for new and existing supplies
Review of in-process, in-operation, and media fill data
Testing of intermediate product produced within the Cleanroom and General Lab
Submit/ prepare shipments of samples to external groups for testing which includes, but is not limited to:
Environmental Monitoring identification
In addition to the tasks above, may be assigned other duties as needed
Supervisor Responsibilities: This Position has no direct supervisory responsibility
Discretion in handling confidential and sensitive matters
Meets department quality standards.
Good time management skills; ability to complete assignments within established timelines.
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
Education, Experience and Licensure
Minimum high school diploma. College credits or college degree preferred.
Minimum of 3-5 years of clinical and/or pharmaceutical lab experience.
Minimum of 1-2 years of working within a GMP environment.
About HEMACARE CORP
HemaCare is a global leader in the customization of human-derived biological products and services. Because of our 40 years of experience, we are the preferred supplier of controlled, consistent, high quality, purified human biological products and unprocessed cellular material, have built the most recallable and reliable donor base in the industry, and successfully performed over 250,000 apheresis collections. With a network of FDA-registered, GMP/GTP-compliant collection centers, expertise in cell processing and isolation, and superior cold chain management, HemaCare directly supports biomedical and drug discovery research, process development, cell therapy clinical trials, and commercialization with apheresis collections, enabling customers to advance both autologous and allogeneic cellular therapies.