Grifols Shared Services North America, Inc Quality Associate II in Marietta, Georgia
Quality Associate II
Marietta Plasma Center - Marietta, GA
QA - Quality Control
Summary:Under the direct supervision of the Center Quality Manager, perform quality assurance functions to ensure compliance with internal and external regulations and protocol.
Primary responsibilities for role:
● 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 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 informaiton if applicale 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 related documentation.
Additional Responsibilities: Is certified and maintains certification in all 3 areas of the donor center. Oversees work of others if applicable.
Knowledge, Skills, and Abilities: Developing command of interpersonal communication, organizational and problem-solving skills. Abilityto understand FDA regulations. Strong integrity and commitment to quality and compliance. Goodknowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexiblescheduling to meet business needs.Proficient in Level 1 position requirements. Performs a higher leveldocument review and employee observations. Communicates openly with CQM on issues noted duringreviews and is able to give suggestions for corrections. Has a good understanding of cGMP and qualitysystems Ability to understand, explain, follow and enforce SOPs, protocols and other regulatoryguidelines. Can work independently, excellent organizational skills, and attention to detail.. Ability toproblem solve at a high level, and therefore assists CQM with investigations and documentationrequired. Has the ability to perform the non-routine activities of the Quality Associate with highproficiency, therefore; performs these functions on a more routine basis with minimal oversight.
Education: High school diploma or GED. Obtains state licensures or certifications if applicable.
Experience: Typically requires 2 years of related experience.
Occupational Demands: 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