Quality Associate- Plasma Biological Service
Company: Grifols Inc.
Posted on: January 15, 2022
For more than 75 years, Grifols has worked to improve the health
and well-being of people around the world. We are a global
healthcare company that produces essential plasma-derived medicines
for patients and provides hospitals and healthcare professionals
with the tools, information and services they need to deliver
expert medical care.
Perform daily donor record file review.
Perform equipment quality control review - daily, weekly, monthly,
semi-annual and annual.
Perform a review of donor center records.
Perform weekly review of equipment incident logs.
Verification and release of sample shipment.
Perform Staging of plasma for shipment.
Inspection and release of incoming supplies.
Perform Weekly employee observations.
Participate in the Quality Assurance meetings and be part of the
Quality Assurance team.
Assist the Center Quality Manager to ensure that cGMP regulations
Assist the Center Quality Manager to ensure that SOPs are followed
and regulatory requirements are met.
Performs a review of the documentation of unsuitable test results
and the disposition of the associated units.
On an occasional basis, when the Center Quality Manager is absent,
the Quality Associate may be required to perform the following
Performs all product release activities.
Documents, investigates, and performs root cause analysis for
deviations and customer complaints, specifically in how they relate
to the safety of the donor and the quality of the product.
Review of equipment records and DMS information if applicable to
approve out of service machines for use.
Review and approval of deferred donor reinstatement activities.
Perform a review of lookback information
Waste shipment review
Initiates investigations and reports any supplies that have not met
quality specifications and requirements prior to use.
Perform a review of medical incident reports and the applicable
Is certified and maintains certification in the donor processing
High school diploma or GED. Obtains state licensures or
certifications if applicable.
Typically requires no previous related experience.
Occupational Demands Form # 70: Work is performed in a plasma
center. Exposure to biological fluids with potential exposure to
infectious organisms. Exposure to electrical office and laboratory
equipment. Exposure to extreme cold below 32 degrees F while
performing reviews in plasma freezers. Personal protective
equipment required such as protective eyewear, garments, gloves and
cold-gear. Work is performed mostly while sitting for up to 4 to 6
hours per day and standing from 2 to 4 hours per day. The position
does require bending and twisting of neck up from 2 to 4 hours per
day. Frequent hand movement of both hands with the ability to make
fast, simple, movements of the fingers, hands, and wrists. Ability
to make precise coordinated movements, of the fingers to grasp and
manipulate objects. Frequent foot movement; may squat, crouch or
sit on one's heels on rare occasion. Occasionally walks, bends and
twists at waist. Light lifting of 15lbs. with a maximum lift of
50lbs. May reach below shoulder height. Hearing acuity essential.
Color perception/discrimination, near vision and far vision
correctable in one eye to 20/30 and to 20/100 in the other eye.
Able to communicate information and ideas so others will
understand; with the ability to listen to and understand
information and ideas presented through spoken words and sentences.
Works independently with little guidance or reliance on oral or
written instructions. Performs a wide range of tasks as dictated by
variable demands and changing conditions. Relates sensitive
information to diverse groups.
Location: NORTH AMERICA : USA : TN-Murfreesboro:USMURF -
Murfreesboro TN-Old Fort-BIO
Keywords: Grifols Inc., Murfreesboro , Quality Associate- Plasma Biological Service, Other , Murfreesboro, Tennessee
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