PURPOSE
OperatesunderthedirectsupervisionOperations Supervisor. Follows and adheres to buyer specifications. Ensure there are no out-of-compliance conditions when processingthe plasma or samples.Complete tasks accurately and in compliance, to set the example for employees undertheirlead.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
- Ensure productintegrity byensuringcompliancewithFoodandDrugAdministration(FDA) regulations, state regulations, ABO’s Standard Operating Procedures (SOP), and any otherapplicableregulatorystandards.
- Organizeproductinstorage freezer,ensuringfreezerorganizationiscompleteandconsistent.
- Perform theQA reviewofdonor samples.
- PerformtheQAreviewofproduct tobeshippedto the consignee.
- Assistwiththeprocessflowinthelab,ensuringthebottlesareenteringthefreezerintheproper time frame.
- CoordinateDailyActivitiesinProcessingArea
- Makedaily assignment incoordinationwithmanager
- Provide preventive maintenance as scheduled on equipment: centrifuge, heat sealers, thermometer,internalfreezer thermometers andgraphrecorders, andcalibrate asnecessary
- Observetechniciansforcompliance
- Assistwithdestroyingunacceptableunits.Quarantineanddiscardunacceptablesamplesand products.
- Manage flow of units coming through the window and ensure compliance in accordance with the SOP.
- Facilitate training of new lab team members in coordination.
- Setup,operateandmaintaininstrumentsusedformanipulating,monitoring,andstoringplasmaproducts(QualityControl).
- Maintaininstrumentsusedforprocessingandstorageofdonorsamplesandproducts.
- Documentoperationalandmaintenanceactivitieswhennecessary.
- Determinesupply inventoryrequirements;orderandrestock,asneeded.
- Communicatedelaysandotherissuesto centermanagement,and/orothernecessaryparties.
- Adheretoall companypolicies, proceduresand safetyrules as stated in the EmployeeHandbook and as otherwise postedor communicated.
- Anyotherdutiesasassigned.
REQUIREMENTS
- Highschooldiplomaorequivalent(Mustbeable toshow proof)
- Strongcustomerserviceskills.
- Must beproficientinEnglish(Read,Write,Speak)withlegiblehandwriting
- CurrentCPR card
- Proficient with computer entry
- Priorsupervisoryskills preferred
- CertifiedasaTrainer
- Six months’ experience in plasma processing (Requirements can be changed by Management, depending on knowledge, skills and abilities.)
- May be required to travel for training
- Bilingual preferred (English/Spanish)
PHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to use hands and fingers to handle and feel objects, tools , or controls; reach with hands and arms. Frequently required to stand, walk, climb , and balance; and stoop, kneel, or crouch. Required to stand for extended periods (2-4 hour intervals). Ability to lift, tug, and pull up to 50 pounds.
WORK ENVIRONMENT
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as protective eyewear, lab coat, gloves and freezer jacket/gloves/pants. Work in a walk-in freezer for short intervals of time (-20C or colder).
