Quality Assurance Specialist
2 weeks ago
Grifols, a global healthcare company, is seeking a Quality Systems Associate to join our team. As a Quality Systems Associate, you will play a critical role in ensuring compliance with internal and external regulations and protocols.
Key Responsibilities:- Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.
- Review and investigate deviations and customer complaints related to product quality and donor safety.
- Inspect and release incoming supplies, and investigate and report supplies that do not meet quality specifications.
- Perform documentation review for unsuitable test results.
- Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
- Perform all product release activities.
- Review lookback information and documentation.
- Review waste shipment documentation.
- Review unexpected plasmapheresis events, including electronic donor chart and related documentation.
- Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Review donor deferral notifications from competitor centers.
- Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
- High school diploma or GED.
- Obtain state licensures or certifications if applicable.
- Typically requires no previous related experience.
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.
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