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Quality Assurance Coordinator - Wyncote, United States - B Positive National Blood Services LLC
Description
Job Type Full-timeDescriptionThe 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 standardsEssential 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 consistentPerform the QA review of product to be shipped to the consigneeSet up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO processMaintain instruments/equipment used for processing and/or qualifying and storage of donor samples and products.
This includes ensuring the instruments/equipment is functioning/cleaned properlyDocument 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 proceduresOversees and performs destruction of unsuitable units.
Quarantine and discard unacceptable samples and productsOversees release and shipment of biohazardous wastePerforms internal audits and quality checks on-siteAssists Quality Assurance Manager and Center Manager with employee training and counseling as needed Oversees receipt of center inventory, including donation softgood supplies and QC reagentsOversees 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 centerOversee the daily management of samples to the testing lab.
Responsible to pack and ship samples to the testing labAssists 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 shippedAssists in shipment of product from the center.
Completes and reviews shipment paperwork required for each product shipmentReports to the Quality Manager any deviations or quality concerns observed at the centerAssists with qualifying and reviewing equipmentAvailable to travel up to 25 miles to other facility(ies) for training or assisting other center's staffing needsOther duties, as assigned RequirementsEducation: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 documentsHear doorbells, alarms, telephone, and other mechanical devicesWork confidently while being observed during frequent quality inspectionsWork in walk in - Subzero freezer(s)
Ability to lift, pull, tug up to 50 pounds to stock supplies and/or move or support donorsRegularly required to use hands and fingers, to handle & feel objects, tools and controls; reach with hands and arms.
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 glovesB Positive Plasma Offers:
Competitive WagesFlexible schedulingPositive Work EnvironmentPaid training opportunitiesComprehensive Medical and Dental BenefitsPaid Time Off401(K)
