Quality Systems Associate
Listed on 2026-01-27
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Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Summary
Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
Primary responsibilities- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
- Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
Is certified and maintains certification as a Donor Center Technician.
Knowledge, Skills, and AbilitiesDeveloping command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols.
Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail.
High school diploma or GED. Obtains state licensures or certifications if applicable.
ExperienceTypically requires no previous related experience.
LocationNorth America: USA: TX-Longview: US Long - Longview TX-S. High Street-BIO
Equal Employment OpportunityGrifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.#J-18808-Ljbffr
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