Quality Associate

Primary responsibilities

• Perform daily donor record file review.
• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual.
• 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.
• Participate in the Quality Assurance meetings and be part of the Quality Assurance team.
• Assist the Center Quality Manager to ensure that cGMP regulations are followed.
• 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 duties:
• 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.

Primary Requirements

Additional Responsibilities
Is certified and maintains certification in the donor processing area.
Education
High school diploma or GED. Obtains state licensures or certifications if applicable.
Experience
Typically requires no previous related experience.
Occupational Demands
Exposure to biological fluids with potential exposure to infectious organisms. 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.. 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. 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.

EEO Minorities/Females/Disability/Veterans

CLK789 #biomatusa

Location: NORTH AMERICA : USA : FL-Sarasota:USSAR - Sarasota FL-Lockwood Ridge Road-BIO

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