The Quality Assurance Coordinator will perform under the supervision of the Quality Assurance Manager, and at times will take instruction and tasks from the Center Manager and Director of Quality Assurance. The Quality Assurance Coordinator will ensure product integrity, and the continued good health of donors through the 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 Duties and Responsibilities (the following list is intended to be a guideline. Other duties and responsibilities may be assigned):
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
Assists 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
Assists 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
Oversee the daily management of samples to the testing lab. Responsible to pack and ship samples to the testing lab
Assists 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
Assists 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
Assists with qualifying and reviewing equipment
Available to travel up to 25 miles to other facility(ies) for training or assisting other center's staffing needs
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.
Vision abilities required by this job, including close vision.
Required to stand for extended intervals, walk, climb and balance; stoop, kneel and crouch.
Physical ability to operate equipment used that may require repetitive motion and manual dexterity.
Ability to read while standing or sitting in front of a computer for extended periods of time (2-3 hours).
Must wear personal protective equipment (PPE) required such as eyewear, lab coats, and gloves
Quality Assurance Coordinator