Quality Assurance Coordinator

Essential Duties and Responsibilities

• Organize product in storage freezer, ensuring freezer organization is complete and consistent
• Perform the QA review of product to be shipped to the consignee
• Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
• Maintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products. This includes ensuring the instruments/equipment is functioning/cleaned properly
• Document operational and maintenance activities when necessary
• Affords assistance to the Quality Assurance Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training are current and consistent with the Company’s Standard Operating Procedures Manual (the “SOP”), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures
• Oversees and performs destruction of unsuitable units. Quarantine and discard unacceptable samples and products
• Oversees release and shipment of biohazardous waste
• Performs internal audits and quality checks on-site
• Affords assistance to the Quality Assurance Manager and Center Manager with employee training and counseling as needed
• Oversees receipt of center inventory, including donation softgood supplies and QC reagents
• Oversees management of lot-controlled supplies, ensuring appropriate use and appropriate storage of supplies per SOP. Ensures supplies are used on a first in, first out basis. QA Approves and releases new supply lots as needed and ensures availability of supplies at the center
• Oversees the daily management of samples to the testing lab. Responsible to pack and ship samples to the testing lab
• Affords assistance in the performance of final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications, and ensures the integrity and quality of the product shipped
• Affords assistance in shipment of product from the center. Completes and reviews shipment paperwork required for each product shipment
• Reports to the Quality Manager any deviations or quality concerns observed at the center
• Affords assistance in qualifying and reviewing equipment
• Affords assistance in traveling up to 25 miles to other facility(ies) for training or assisting other center's staffing needs
• Completes other duties, as assigned

Requirements

• Education: High School Diploma, required; Associate's or Bachelor's degree, preferred in Management, Business, Nursing, Finance, or science related field
• Skills And Qualifications: Excellent verbal and written communication skills.Excellent interpersonal and customer service skills.Excellent organizational skills and attention to detail.Consultation. Ethical Practice.Cultural Awareness.Business Acumen.Relationship Management.Strong computer skills; Familiarity with Microsoft Office applications.

Physical Requirements

• Read computer screens, procedure manuals and other documents
• Hear doorbells, alarms, telephone, and other mechanical devices
• Work confidently while being observed during frequent quality inspections
• Work in walk in - Subzero freezer(s)
• Ability to lift, pull, tug up to 50 pounds to stock supplies and/or move or support donors
• Regularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms
• Work in a regular work environment